Age-Related Maculopathies, Age-Related Maculopathy, Eye Diseases, Macular Degeneration, Retinal Degeneration
Conditions
Keywords
Phase 1b Advanced Dry Age-Related Macular Degeneration RN6G
Brief summary
The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.
Interventions
Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg
Intravenous, multiple dose with experimental dose
Sponsors
Study design
Eligibility
Inclusion criteria
* Be of non-child bearing potential * Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement * BCVA of 20/50 or better in the study eye
Exclusion criteria
* Evidence of ocular disease other than advanced AMD or GA in the study eye * History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study eye * Presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or gastrointestinal system * Requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Toxicity or Intolerable Dose Criteria | Baseline up to Day 304/End of Treatment (ET) | The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade \>= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade \>= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval \[Fridericia's correction\]), Grade \>=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia \<100\*10 9 /liter. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Baseline up to Day 304/ET | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. AE was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE). |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Baseline up to Day 304/ET | All causalities AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship. Drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. All causalities and drug-related AEs reported wherein drug-related AEs were reported as ocular and non-ocular AEs. Ocular AEs were events which were localized in the ocular region and non-ocular AEs were systemic events which were not localized but occurred throughout the systemic circulation. |
| Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Baseline up to Day 304/ET | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AE were events which were localized in the ocular region and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE). |
| Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Baseline up to Day 304/ET | AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were events which were localized in the ocular region. Ocular AEs reported as related and non-related to study drug. |
| Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Baseline up to Day 304/ET | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic AE were events which were not localized but occurred throughout the systemic circulation and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE). |
| Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Baseline up to Day 304/ET | AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic TEAEs were events which were not localized but occurred throughout the systemic circulation and reported as related and non-related to study drug. |
| Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) | Baseline up to Day 304/ET | The immunogenicity of RN6G (PF-04382923) in terms of producing an antidrug antibody (ADA) and neutralizing antibody response were assessed. Neutralizing antibody response were to be assess in participants with positive ADA samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET | Amyloid (A) Beta (1-X) is a primary activator of complement in Alzheimer's disease (AD). |
| Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET | — |
| Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET | — |
| Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline, Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET | — |
| Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET | — |
| Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET | — |
| Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET | — |
| Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline, 1 and 4 hour (H) post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET | — |
| Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET | — |
| Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET | — |
| Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET | Criteria for changes in ECG (12-lead) were defined as: PR interval \>=220 millisecond (msec) and increase of \>=20 msec; QRS interval \>=120 msec; QT interval corrected using the Bazett's formula (QTcB) \>=500 msec; Maximum Change from Baseline in QTcF at Borderline \>=30 msec to \<60 msec and Prolonged \>=60 msec. |
| Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET | — |
| Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Following parameters were analyzed for laboratory examination: Bilirubin, Direct Bilirubin, Blood Urea Nitrogen(BUN), Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol (CL)(Fasting), Triglycerides (Fasting) (TG), Immunoglobulin G (Ig G), Immunoglobulin A (Ig A), Immunoglobulin M (Ig M) |
| Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | — |
| Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Following parameters were analyzed for laboratory examination: Aspartate Aminotransferase (AMT), Creatine Kinase (CK), Alanine Aminotransferase (ALT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD), Alkaline Phosphatase (AP). |
| Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | — |
| Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Following hematology parameters were analyzed for laboratory examination: Hemoglobin, Hematocrit, Red blood cell (RBC) count, Platelet count, WBC count, Total neutrophils (Abs),Eosinophils (Abs),Monocytes (Abs),Basophils (Abs), Lymphocytes (Abs). |
| Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | — |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672 hours on Day 140 | Area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau = 672 hours. |
| Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Following hematology parameters were analyzed for laboratory examination: Prothrombin Time (PT), Partial Thromboplastin Time. |
| Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Urine specific gravity is a measure of the ratio of the density of urine to the density of water. |
| Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Urine pH is a method for evaluating urine acidity measured on a 10-point scale ranging from 0 (most acidic) to 9 (most alkaline). A lower pH means more acidity. |
| Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline, Day 28, 56, 84, 112, 140 | — |
| Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline, Day 28, 56, 84, 112, 140 | — |
| Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Baseline, Day 28, 56, 84, 112, 140 | — |
| Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | — |
| Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET | QT interval corrected using the Fridericia formula (QTcF) \>=500 msec; Maximum Change from Baseline in QTcF at Borderline \>=30 msec to \<60 msec and Prolonged \>=60 msec. |
| Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | — |
| Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | — |
| Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | — |
| Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | Css is the concentration of the drug at the state when the amount of drug administered is equal to the amount of drug eliminated. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | — |
| Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Mean Residence Time (MRT) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | The mean total time drug resides in the body. |
| Systemic Clearance (CL) of RN6G (PF-04382923) | Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RN6G 5 mg/kg RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | 6 |
| RN6G 10 mg/kg RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | 6 |
| RN6G 15 mg/kg RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | 6 |
| Placebo Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5. | 6 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | RN6G 5 mg/kg | RN6G 10 mg/kg | RN6G 15 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Customized 60 to less than (<) 75 years | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 11 Participants |
| Age, Customized Greater than or equal to (>=) 75 years | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 23 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 1 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 2 / 6 | 0 / 6 |
Outcome results
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were events which were localized in the ocular region. Ocular AEs reported as related and non-related to study drug.
Time frame: Baseline up to Day 304/ET
Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not Related | 4 Participants |
| RN6G 10 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not Related | 4 Participants |
| RN6G 10 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not Related | 3 Participants |
| Placebo | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 0 Participants |
| Placebo | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not Related | 4 Participants |
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AE were events which were localized in the ocular region and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Time frame: Baseline up to Day 304/ET
Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 4 Participants |
| RN6G 5 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 4 Participants |
| RN6G 10 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 3 Participants |
| RN6G 15 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| Placebo | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| Placebo | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 2 Participants |
| Placebo | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 2 Participants |
| Placebo | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| Placebo | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab)
The immunogenicity of RN6G (PF-04382923) in terms of producing an antidrug antibody (ADA) and neutralizing antibody response were assessed. Neutralizing antibody response were to be assess in participants with positive ADA samples.
Time frame: Baseline up to Day 304/ET
Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here Number Analyzed signifies number of participants evaluated for specified category. Data for Nab was not estimable as no participant was eligible for neutralizing antibody assessment, as there were no positive ADA samples.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) | Positive ADA | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) | Positive ADA | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) | Positive ADA | 0 Participants |
| Placebo | Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) | Positive ADA | 0 Participants |
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic TEAEs were events which were not localized but occurred throughout the systemic circulation and reported as related and non-related to study drug.
Time frame: Baseline up to Day 304/ET
Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 2 Participants |
| RN6G 5 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not related | 4 Participants |
| RN6G 10 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not related | 6 Participants |
| RN6G 10 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not related | 6 Participants |
| RN6G 15 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 0 Participants |
| Placebo | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Related | 0 Participants |
| Placebo | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | Not related | 6 Participants |
Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic AE were events which were not localized but occurred throughout the systemic circulation and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Time frame: Baseline up to Day 304/ET
Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 5 Participants |
| RN6G 5 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 1 Participants |
| RN6G 5 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 3 Participants |
| RN6G 10 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 3 Participants |
| RN6G 10 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 2 Participants |
| RN6G 15 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 4 Participants |
| RN6G 15 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| Placebo | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 5 Participants |
| Placebo | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| Placebo | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| Placebo | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 0 Participants |
| Placebo | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 1 Participants |
Number of Participants With Toxicity or Intolerable Dose Criteria
The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade \>= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade \>= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval \[Fridericia's correction\]), Grade \>=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia \<100\*10 9 /liter.
Time frame: Baseline up to Day 304/End of Treatment (ET)
Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Toxicity or Intolerable Dose Criteria | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Toxicity or Intolerable Dose Criteria | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Toxicity or Intolerable Dose Criteria | 0 Participants |
| Placebo | Number of Participants With Toxicity or Intolerable Dose Criteria | 0 Participants |
Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug
All causalities AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship. Drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. All causalities and drug-related AEs reported wherein drug-related AEs were reported as ocular and non-ocular AEs. Ocular AEs were events which were localized in the ocular region and non-ocular AEs were systemic events which were not localized but occurred throughout the systemic circulation.
Time frame: Baseline up to Day 304/ET
Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | All causalities AE | 6 Participants |
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related non-ocular AE | 2 Participants |
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related Ocular AE | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | All causalities AE | 6 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related non-ocular AE | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related Ocular AE | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related Ocular AE | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | All causalities AE | 6 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related non-ocular AE | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | All causalities AE | 6 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related non-ocular AE | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | Drug-related Ocular AE | 0 Participants |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. AE was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Time frame: Baseline up to Day 304/ET
Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 5 Participants |
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| RN6G 5 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 1 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 3 Participants |
| RN6G 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 3 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 2 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 4 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| RN6G 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 4 | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 2 | 5 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 1 | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 3 | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | Grade 5 | 0 Participants |
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923)
Area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau = 672 hours.
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672 hours on Day 140
Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluated for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) | Day 1 | NA Microgram*hour per milliliter (mcg*h/mL) | — |
| RN6G 5 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) | Day 140 | 50230 Microgram*hour per milliliter (mcg*h/mL) | Geometric Coefficient of Variation 20 |
| RN6G 10 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) | Day 140 | 140300 Microgram*hour per milliliter (mcg*h/mL) | Geometric Coefficient of Variation 14 |
| RN6G 15 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) | Day 1 | NA Microgram*hour per milliliter (mcg*h/mL) | — |
| RN6G 15 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) | Day 140 | 213200 Microgram*hour per milliliter (mcg*h/mL) | Geometric Coefficient of Variation 16 |
Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Criteria for changes in ECG (12-lead) were defined as: PR interval \>=220 millisecond (msec) and increase of \>=20 msec; QRS interval \>=120 msec; QT interval corrected using the Bazett's formula (QTcB) \>=500 msec; Maximum Change from Baseline in QTcF at Borderline \>=30 msec to \<60 msec and Prolonged \>=60 msec.
Time frame: Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET
Population: Safety analysis set included all randomized participants who received any amount of study drug. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: RR | -36.28 Millisecond | Standard Deviation 38.148 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcB | -2.06 Millisecond | Standard Deviation 16.679 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: PR | -6.78 Millisecond | Standard Deviation 9.27 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcB | -0.61 Millisecond | Standard Deviation 9.855 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QT | -3.78 Millisecond | Standard Deviation 18.493 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcB | -6.39 Millisecond | Standard Deviation 18.637 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcB | -6.39 Millisecond | Standard Deviation 17.989 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: PR | 0.22 Millisecond | Standard Deviation 6.885 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QRS | -4.44 Millisecond | Standard Deviation 5.106 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: RR | 5.39 Millisecond | Standard Deviation 61.533 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcB | -2.11 Millisecond | Standard Deviation 6.493 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: PR | -0.78 Millisecond | Standard Deviation 12.567 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QT | -2.33 Millisecond | Standard Deviation 11.939 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QT | -1.33 Millisecond | Standard Deviation 13.367 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcB | 4.44 Millisecond | Standard Deviation 13.274 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: PR | 2.33 Millisecond | Standard Deviation 8.892 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RR | 939.28 Millisecond | Standard Deviation 124.486 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RR | -33.11 Millisecond | Standard Deviation 80.934 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcB | -5.39 Millisecond | Standard Deviation 11.496 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: PR | -3.33 Millisecond | Standard Deviation 7.76 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RR | 21.72 Millisecond | Standard Deviation 77.289 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QRS | -2.44 Millisecond | Standard Deviation 6.017 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcB | 0.39 Millisecond | Standard Deviation 4.823 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: PR | -4.33 Millisecond | Standard Deviation 9.177 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QRS | -2.56 Millisecond | Standard Deviation 3.538 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: RR | -7.61 Millisecond | Standard Deviation 53.735 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QT | -4.67 Millisecond | Standard Deviation 24.909 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PR | -4.11 Millisecond | Standard Deviation 8.405 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QT | -1.00 Millisecond | Standard Deviation 5.379 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: RR | -6.78 Millisecond | Standard Deviation 120.518 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcB | 418.56 Millisecond | Standard Deviation 13.605 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PR | -7.11 Millisecond | Standard Deviation 14.09 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcB | -6.89 Millisecond | Standard Deviation 9.135 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: RR | 4.06 Millisecond | Standard Deviation 45.449 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PR | 170.78 Millisecond | Standard Deviation 23.268 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: RR | -44.61 Millisecond | Standard Deviation 76.284 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcB | 0.72 Millisecond | Standard Deviation 9.525 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QT | -3.44 Millisecond | Standard Deviation 12.274 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QRS | 87.11 Millisecond | Standard Deviation 5.036 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QT | 405.00 Millisecond | Standard Deviation 25.174 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: RR | 30.56 Millisecond | Standard Deviation 23.478 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QT | -1.67 Millisecond | Standard Deviation 6.782 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QRS | -2.67 Millisecond | Standard Deviation 4.881 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: PR | -4.22 Millisecond | Standard Deviation 13.589 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QRS | -2.22 Millisecond | Standard Deviation 3.202 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: RR | 29.56 Millisecond | Standard Deviation 40.059 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QRS | -1.78 Millisecond | Standard Deviation 4.856 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcB | -0.89 Millisecond | Standard Deviation 8.516 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: PR | -1.33 Millisecond | Standard Deviation 9.762 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QT | -13.00 Millisecond | Standard Deviation 17.255 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QRS | 1.56 Millisecond | Standard Deviation 4.375 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QRS | -2.67 Millisecond | Standard Deviation 4.638 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QT | -2.33 Millisecond | Standard Deviation 15.769 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1H post-dose Day 1: QT | 1.22 Millisecond | Standard Deviation 14.27 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QRS | -1.44 Millisecond | Standard Deviation 2.083 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: PR | -2.78 Millisecond | Standard Deviation 11.711 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: RR | -6.39 Millisecond | Standard Deviation 43.272 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QT | -10.22 Millisecond | Standard Deviation 12.174 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QRS | -2.11 Millisecond | Standard Deviation 3.331 |
| RN6G 5 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QRS | -3.11 Millisecond | Standard Deviation 7.101 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QRS | -1.44 Millisecond | Standard Deviation 3.41 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcB | -14.78 Millisecond | Standard Deviation 38.322 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QT | -13.00 Millisecond | Standard Deviation 17.006 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QRS | 0.22 Millisecond | Standard Deviation 5.054 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: RR | -39.89 Millisecond | Standard Deviation 85.486 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QRS | -0.11 Millisecond | Standard Deviation 6.217 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QT | -18.00 Millisecond | Standard Deviation 35.7 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QRS | 1.56 Millisecond | Standard Deviation 4.593 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QRS | 1.22 Millisecond | Standard Deviation 5.439 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QT | -6.00 Millisecond | Standard Deviation 14.092 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QRS | 0.67 Millisecond | Standard Deviation 6.613 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QRS | -0.22 Millisecond | Standard Deviation 4.456 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: RR | -16.83 Millisecond | Standard Deviation 58.974 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QT | -9.33 Millisecond | Standard Deviation 17.42 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QRS | 1.89 Millisecond | Standard Deviation 5.34 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QRS | 0.22 Millisecond | Standard Deviation 3.569 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcB | 3.17 Millisecond | Standard Deviation 11.201 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QRS | 1.22 Millisecond | Standard Deviation 6.895 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QT | -11.33 Millisecond | Standard Deviation 13.914 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QT | 422.00 Millisecond | Standard Deviation 29.835 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: RR | -66.17 Millisecond | Standard Deviation 86.676 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1H post-dose Day 1: QT | 2.22 Millisecond | Standard Deviation 11.713 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QT | -8.67 Millisecond | Standard Deviation 10.302 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QT | -13.44 Millisecond | Standard Deviation 19.018 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QT | -11.33 Millisecond | Standard Deviation 17.42 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RR | -31.78 Millisecond | Standard Deviation 27.507 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RR | 8.89 Millisecond | Standard Deviation 58.224 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: RR | -34.22 Millisecond | Standard Deviation 82.327 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcB | -4.33 Millisecond | Standard Deviation 8.899 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: RR | 32.39 Millisecond | Standard Deviation 70.6 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RR | 962.44 Millisecond | Standard Deviation 117.246 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PR | 190.00 Millisecond | Standard Deviation 38.006 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcB | 1.33 Millisecond | Standard Deviation 13.471 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcB | -9.33 Millisecond | Standard Deviation 16.35 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: PR | -4.33 Millisecond | Standard Deviation 9.407 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: PR | -4.89 Millisecond | Standard Deviation 6.898 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: RR | 0.39 Millisecond | Standard Deviation 53.575 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcB | -4.67 Millisecond | Standard Deviation 9.92 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: PR | 1.00 Millisecond | Standard Deviation 10.673 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QTcB | -9.5 Millisecond | Standard Deviation 15.812 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcB | -12.50 Millisecond | Standard Deviation 14.442 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: PR | 0.33 Millisecond | Standard Deviation 15.842 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: PR | -8.33 Millisecond | Standard Deviation 18.426 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcB | -6.67 Millisecond | Standard Deviation 14.188 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: PR | -3.33 Millisecond | Standard Deviation 18.086 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: RR | -19.78 Millisecond | Standard Deviation 32.654 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: PR | -1.11 Millisecond | Standard Deviation 14.052 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcB | -12.33 Millisecond | Standard Deviation 13.105 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcB | -3.50 Millisecond | Standard Deviation 6.483 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: PR | -1.56 Millisecond | Standard Deviation 11.938 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcB | 1.83 Millisecond | Standard Deviation 9.697 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: PR | 2.00 Millisecond | Standard Deviation 8.316 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcB | 430.67 Millisecond | Standard Deviation 20.976 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PR | -7.00 Millisecond | Standard Deviation 12.994 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: RR | -12.78 Millisecond | Standard Deviation 56.646 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PR | -1.00 Millisecond | Standard Deviation 15.468 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QT | -1.67 Millisecond | Standard Deviation 16.896 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PR | -3.00 Millisecond | Standard Deviation 19.066 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QT | -9.67 Millisecond | Standard Deviation 12.442 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QRS | 91.44 Millisecond | Standard Deviation 8.352 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QRS | -1.56 Millisecond | Standard Deviation 3.417 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: RR | -24.11 Millisecond | Standard Deviation 63.637 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QT | -5.67 Millisecond | Standard Deviation 11.939 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QRS | -1.67 Millisecond | Standard Deviation 2.692 |
| RN6G 10 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: RR | 24.94 Millisecond | Standard Deviation 70.632 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RR | 60.44 Millisecond | Standard Deviation 122.291 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RR | 918.39 Millisecond | Standard Deviation 101.325 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: RR | 79.11 Millisecond | Standard Deviation 89.729 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: RR | 22.33 Millisecond | Standard Deviation 115.576 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: RR | 69.44 Millisecond | Standard Deviation 91.732 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: RR | 74.78 Millisecond | Standard Deviation 98.804 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: RR | 57.11 Millisecond | Standard Deviation 102.514 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: RR | 34.94 Millisecond | Standard Deviation 77.744 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: RR | 26.56 Millisecond | Standard Deviation 91.107 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: RR | 80.44 Millisecond | Standard Deviation 104.487 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: RR | 52.17 Millisecond | Standard Deviation 86.145 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RR | -22.72 Millisecond | Standard Deviation 99.733 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: RR | -9.22 Millisecond | Standard Deviation 80.263 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PR | 167.89 Millisecond | Standard Deviation 25.711 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: PR | -7.11 Millisecond | Standard Deviation 12.261 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: PR | -6.33 Millisecond | Standard Deviation 7.563 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: PR | 28.44 Millisecond | Standard Deviation 84.486 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: PR | -11.47 Millisecond | Standard Deviation 22.912 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: PR | -0.67 Millisecond | Standard Deviation 1.944 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: PR | -13.56 Millisecond | Standard Deviation 22.134 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: PR | -4.22 Millisecond | Standard Deviation 5.311 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: PR | -4.67 Millisecond | Standard Deviation 14.569 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: PR | -7.89 Millisecond | Standard Deviation 11.262 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PR | -2.56 Millisecond | Standard Deviation 5.154 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PR | -7.89 Millisecond | Standard Deviation 7.061 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PR | -17.22 Millisecond | Standard Deviation 21.935 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QRS | 97.89 Millisecond | Standard Deviation 22.444 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QRS | -2.33 Millisecond | Standard Deviation 2.789 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QRS | 0.44 Millisecond | Standard Deviation 2.373 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QRS | -0.89 Millisecond | Standard Deviation 2.656 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QRS | 1.78 Millisecond | Standard Deviation 2.722 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QRS | 6.78 Millisecond | Standard Deviation 22.333 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QRS | 5.11 Millisecond | Standard Deviation 20.149 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QRS | 0.33 Millisecond | Standard Deviation 2.883 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QRS | 1.22 Millisecond | Standard Deviation 2.083 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QRS | -0.44 Millisecond | Standard Deviation 1.44 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QRS | 2.11 Millisecond | Standard Deviation 4.53 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QRS | 9.78 Millisecond | Standard Deviation 26.712 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QRS | -2.56 Millisecond | Standard Deviation 1.76 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QT | 408.56 Millisecond | Standard Deviation 30.56 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1H post-dose Day 1: QT | 14.22 Millisecond | Standard Deviation 14.845 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QT | 4.67 Millisecond | Standard Deviation 29.796 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QT | 11.11 Millisecond | Standard Deviation 14.228 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QT | 18.44 Millisecond | Standard Deviation 31.865 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QT | 14.11 Millisecond | Standard Deviation 26.319 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QT | 5.44 Millisecond | Standard Deviation 13.607 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QT | 11.89 Millisecond | Standard Deviation 18.621 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QT | 22.33 Millisecond | Standard Deviation 22.17 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QT | 19.67 Millisecond | Standard Deviation 14.34 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QT | 16.44 Millisecond | Standard Deviation 36.302 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QT | -1.22 Millisecond | Standard Deviation 27.995 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QT | -8.56 Millisecond | Standard Deviation 31.792 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcB | 426.28 Millisecond | Standard Deviation 18.37 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcB | -2.67 Millisecond | Standard Deviation 12.006 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcB | -0.11 Millisecond | Standard Deviation 6.811 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcB | -2.94 Millisecond | Standard Deviation 18.639 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcB | 1.56 Millisecond | Standard Deviation 15.45 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcB | 2.22 Millisecond | Standard Deviation 21.281 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcB | -1.11 Millisecond | Standard Deviation 9.66 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcB | 6.94 Millisecond | Standard Deviation 6.641 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcB | 4.72 Millisecond | Standard Deviation 10.794 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcB | 9.06 Millisecond | Standard Deviation 11.144 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcB | 4.06 Millisecond | Standard Deviation 10.81 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcB | 3.72 Millisecond | Standard Deviation 14.188 |
| RN6G 15 mg/kg | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QTcB | -6.28 Millisecond | Standard Deviation 17.655 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QRS | -0.33 Millisecond | Standard Deviation 2.261 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QTcB | 13.17 Millisecond | Standard Deviation 8.813 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QT | 11.33 Millisecond | Standard Deviation 35.308 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QRS | 0.78 Millisecond | Standard Deviation 3.41 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QRS | 0.78 Millisecond | Standard Deviation 1.76 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcB | 11.33 Millisecond | Standard Deviation 18.318 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QT | 4.27 Millisecond | Standard Deviation 26.594 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QRS | 100.33 Millisecond | Standard Deviation 24.858 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PR | 16.33 Millisecond | Standard Deviation 21.709 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: RR | -51.67 Millisecond | Standard Deviation 186.668 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QT | 19.22 Millisecond | Standard Deviation 22.225 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PR | 14.13 Millisecond | Standard Deviation 24.214 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: RR | 8.83 Millisecond | Standard Deviation 65.44 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QT | 9.33 Millisecond | Standard Deviation 36.127 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PR | -1.50 Millisecond | Standard Deviation 10.932 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: PR | 21.87 Millisecond | Standard Deviation 28.757 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcB | 6.72 Millisecond | Standard Deviation 17.425 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcB | 417.11 Millisecond | Standard Deviation 17.539 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: PR | 16.27 Millisecond | Standard Deviation 22.229 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: PR | 11.33 Millisecond | Standard Deviation 23.636 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcB | 11.80 Millisecond | Standard Deviation 20.895 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcB | 5.81 Millisecond | Standard Deviation 17.269 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: PR | 16.53 Millisecond | Standard Deviation 26.764 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: PR | 11.73 Millisecond | Standard Deviation 32.392 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: RR | 49.00 Millisecond | Standard Deviation 78.316 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcB | 13.50 Millisecond | Standard Deviation 29.257 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: PR | 12.22 Millisecond | Standard Deviation 23.512 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QRS | 0.00 Millisecond | Standard Deviation 4.922 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: RR | -54.11 Millisecond | Standard Deviation 94.978 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcB | -5.94 Millisecond | Standard Deviation 5.953 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: PR | 3.89 Millisecond | Standard Deviation 12.245 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: PR | -2.89 Millisecond | Standard Deviation 6.362 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RR | -28.67 Millisecond | Standard Deviation 70.982 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcB | 5.39 Millisecond | Standard Deviation 19.841 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: PR | -2.67 Millisecond | Standard Deviation 6.902 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PR | 166.11 Millisecond | Standard Deviation 41.177 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcB | 10.07 Millisecond | Standard Deviation 21.177 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcB | 23.07 Millisecond | Standard Deviation 32.116 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: RR | -11.92 Millisecond | Standard Deviation 122.446 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RR | 56.50 Millisecond | Standard Deviation 78.87 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: RR | -21.22 Millisecond | Standard Deviation 136.555 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcB | 29.07 Millisecond | Standard Deviation 42.361 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: RR | 5.13 Millisecond | Standard Deviation 166.054 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QT | 4.89 Millisecond | Standard Deviation 18.29 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QT | 1.56 Millisecond | Standard Deviation 32.457 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1H post-dose Day 1: QT | 0.78 Millisecond | Standard Deviation 26.346 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: RR | 42.60 Millisecond | Standard Deviation 150.052 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QT | 8.22 Millisecond | Standard Deviation 10.221 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QT | 401.78 Millisecond | Standard Deviation 31.932 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QRS | 5.83 Millisecond | Standard Deviation 4.631 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RR | 928.33 Millisecond | Standard Deviation 117.701 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QT | 10.27 Millisecond | Standard Deviation 28.482 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QRS | 1.00 Millisecond | Standard Deviation 2.692 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QRS | 2.53 Millisecond | Standard Deviation 5.586 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcB | 9.33 Millisecond | Standard Deviation 22.955 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QT | 19.07 Millisecond | Standard Deviation 35.345 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QRS | 0.40 Millisecond | Standard Deviation 4.681 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QRS | -0.40 Millisecond | Standard Deviation 4.017 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: RR | -9.60 Millisecond | Standard Deviation 51.462 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QT | 7.47 Millisecond | Standard Deviation 25.304 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QRS | 0.80 Millisecond | Standard Deviation 4.84 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QRS | 1.60 Millisecond | Standard Deviation 9.541 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: RR | -44.87 Millisecond | Standard Deviation 82.091 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QT | 19.33 Millisecond | Standard Deviation 28.091 |
| Placebo | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QRS | -2.67 Millisecond | Standard Deviation 6.037 |
Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Following parameters were analyzed for laboratory examination: Bilirubin, Direct Bilirubin, Blood Urea Nitrogen(BUN), Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol (CL)(Fasting), Triglycerides (Fasting) (TG), Immunoglobulin G (Ig G), Immunoglobulin A (Ig A), Immunoglobulin M (Ig M)
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point. Categories with at least 1 non-zero data have been provided below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.075 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Calcium | 0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.55 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Creatinine | 0.008 Milligram per deciliter (MG/DL) | Standard Deviation 0.1121 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Calcium | 0.13 Milligram per deciliter (MG/DL) | Standard Deviation 0.367 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bilirubin | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.082 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Creatinine | 0.020 Milligram per deciliter (MG/DL) | Standard Deviation 0.1316 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Calcium | -0.15 Milligram per deciliter (MG/DL) | Standard Deviation 0.638 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Glucose | 22.8 Milligram per deciliter (MG/DL) | Standard Deviation 48.16 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Calcium | 0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.369 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: TG (fasting) | -15.0 Milligram per deciliter (MG/DL) | Standard Deviation 45.79 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: TG (fasting) | 4.2 Milligram per deciliter (MG/DL) | Standard Deviation 63.29 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Direct Bilirubin | 0.15 Milligram per deciliter (MG/DL) | Standard Deviation 0.055 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Uric Acid | -0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.497 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Creatinine | 0.053 Milligram per deciliter (MG/DL) | Standard Deviation 0.0755 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Glucose | 93.8 Milligram per deciliter (MG/DL) | Standard Deviation 11.2 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Direct Bilirubin | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.052 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Phosphate | 0.22 Milligram per deciliter (MG/DL) | Standard Deviation 0.417 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CL (fasting) | -6.5 Milligram per deciliter (MG/DL) | Standard Deviation 35.23 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Uric Acid | 0.62 Milligram per deciliter (MG/DL) | Standard Deviation 1.072 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.063 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Uric Acid | -0.08 Milligram per deciliter (MG/DL) | Standard Deviation 0.722 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CL (fasting) | -9.0 Milligram per deciliter (MG/DL) | Standard Deviation 13.28 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Creatinine | -0.002 Milligram per deciliter (MG/DL) | Standard Deviation 0.1321 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.063 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Creatinine | 0.918 Milligram per deciliter (MG/DL) | Standard Deviation 0.2322 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: TG (fasting) | -11.5 Milligram per deciliter (MG/DL) | Standard Deviation 43.72 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Phosphate | 0.13 Milligram per deciliter (MG/DL) | Standard Deviation 0.472 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.075 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CL (fasting) | -2.5 Milligram per deciliter (MG/DL) | Standard Deviation 17.13 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Uric Acid | -0.32 Milligram per deciliter (MG/DL) | Standard Deviation 0.571 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Glucose | 0.7 Milligram per deciliter (MG/DL) | Standard Deviation 6.28 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Direct Bilirubin | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.052 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bilirubin | 0.48 Milligram per deciliter (MG/DL) | Standard Deviation 0.147 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: TG (fasting) | 141.7 Milligram per deciliter (MG/DL) | Standard Deviation 47.32 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Phosphate | 0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.459 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.041 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Uric Acid | 0.23 Milligram per deciliter (MG/DL) | Standard Deviation 0.855 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Uric Acid | -0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.641 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Creatinine | 0.043 Milligram per deciliter (MG/DL) | Standard Deviation 0.1179 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.075 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Creatinine | 0.047 Milligram per deciliter (MG/DL) | Standard Deviation 0.088 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: TG (fasting) | -24.5 Milligram per deciliter (MG/DL) | Standard Deviation 46 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Phosphate | 0.32 Milligram per deciliter (MG/DL) | Standard Deviation 0.36 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: TG (fasting) | 2.2 Milligram per deciliter (MG/DL) | Standard Deviation 38.57 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Calcium | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.335 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bilirubin | -0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.122 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: BUN | 18.7 Milligram per deciliter (MG/DL) | Standard Deviation 5.01 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Uric Acid | 4.87 Milligram per deciliter (MG/DL) | Standard Deviation 1.172 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CL (fasting) | 0.0 Milligram per deciliter (MG/DL) | Standard Deviation 8.02 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Phosphate | 0.27 Milligram per deciliter (MG/DL) | Standard Deviation 0.308 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: BUN | -0.3 Milligram per deciliter (MG/DL) | Standard Deviation 3.14 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Glucose | 4.7 Milligram per deciliter (MG/DL) | Standard Deviation 5.28 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CL (fasting) | 191.7 Milligram per deciliter (MG/DL) | Standard Deviation 20.34 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bilirubin | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.133 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: BUN | -2.0 Milligram per deciliter (MG/DL) | Standard Deviation 2.1 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CL (fasting) | -4.7 Milligram per deciliter (MG/DL) | Standard Deviation 19.79 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Creatinine | 0.055 Milligram per deciliter (MG/DL) | Standard Deviation 0.171 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Phosphate | 0.27 Milligram per deciliter (MG/DL) | Standard Deviation 0.489 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: BUN | 1.3 Milligram per deciliter (MG/DL) | Standard Deviation 4.32 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Uric Acid | -0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.539 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CL (fasting) | -0.8 Milligram per deciliter (MG/DL) | Standard Deviation 26.54 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bilirubin | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.082 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: BUN | -0.2 Milligram per deciliter (MG/DL) | Standard Deviation 5.08 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Calcium | 0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.279 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CL (fasting) | 12.3 Milligram per deciliter (MG/DL) | Standard Deviation 14.19 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Phosphate | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.273 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: BUN | 1.0 Milligram per deciliter (MG/DL) | Standard Deviation 4.6 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Glucose | -2.0 Milligram per deciliter (MG/DL) | Standard Deviation 1.41 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bilirubin | -0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.141 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Glucose | 6.8 Milligram per deciliter (MG/DL) | Standard Deviation 4.88 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: BUN | 0.0 Milligram per deciliter (MG/DL) | Standard Deviation 2.45 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: TG (fasting) | 6.0 Milligram per deciliter (MG/DL) | Standard Deviation 73.16 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Calcium | 9.62 Milligram per deciliter (MG/DL) | Standard Deviation 0.248 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Phosphate | 3.20 Milligram per deciliter (MG/DL) | Standard Deviation 0.583 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: BUN | 1.2 Milligram per deciliter (MG/DL) | Standard Deviation 2.14 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bilirubin | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.082 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: TG (fasting) | -23.2 Milligram per deciliter (MG/DL) | Standard Deviation 35.44 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Calcium | -0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.361 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Glucose | -1.0 Milligram per deciliter (MG/DL) | Standard Deviation 6.42 |
| RN6G 5 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Glucose | 1.7 Milligram per deciliter (MG/DL) | Standard Deviation 6.19 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Glucose | 5.8 Milligram per deciliter (MG/DL) | Standard Deviation 12.16 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: BUN | -0.2 Milligram per deciliter (MG/DL) | Standard Deviation 4.07 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CL (fasting) | 1.5 Milligram per deciliter (MG/DL) | Standard Deviation 9.57 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Phosphate | 3.48 Milligram per deciliter (MG/DL) | Standard Deviation 0.376 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: BUN | 0.5 Milligram per deciliter (MG/DL) | Standard Deviation 3.51 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Glucose | 3.3 Milligram per deciliter (MG/DL) | Standard Deviation 5.85 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: BUN | 1.3 Milligram per deciliter (MG/DL) | Standard Deviation 2.8 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Calcium | -0.15 Milligram per deciliter (MG/DL) | Standard Deviation 0.446 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: BUN | 1.5 Milligram per deciliter (MG/DL) | Standard Deviation 2.59 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Calcium | -0.27 Milligram per deciliter (MG/DL) | Standard Deviation 0.393 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: TG (fasting) | 4.0 Milligram per deciliter (MG/DL) | Standard Deviation 68.07 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Creatinine | 0.955 Milligram per deciliter (MG/DL) | Standard Deviation 0.075 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Creatinine | -0.032 Milligram per deciliter (MG/DL) | Standard Deviation 0.0708 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Calcium | -0.32 Milligram per deciliter (MG/DL) | Standard Deviation 0.306 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Creatinine | 0.000 Milligram per deciliter (MG/DL) | Standard Deviation 0.1163 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Glucose | 3.2 Milligram per deciliter (MG/DL) | Standard Deviation 6.11 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Creatinine | 0.038 Milligram per deciliter (MG/DL) | Standard Deviation 0.1196 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Calcium | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.388 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CL (fasting) | 0.2 Milligram per deciliter (MG/DL) | Standard Deviation 10.72 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Creatinine | 0.008 Milligram per deciliter (MG/DL) | Standard Deviation 0.0924 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Creatinine | -0.020 Milligram per deciliter (MG/DL) | Standard Deviation 0.1271 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CL (fasting) | -2.5 Milligram per deciliter (MG/DL) | Standard Deviation 8.57 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Creatinine | -0.045 Milligram per deciliter (MG/DL) | Standard Deviation 0.0922 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Calcium | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.344 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Creatinine | 0.012 Milligram per deciliter (MG/DL) | Standard Deviation 0.1297 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: TG (fasting) | -24.7 Milligram per deciliter (MG/DL) | Standard Deviation 57.41 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Calcium | -0.22 Milligram per deciliter (MG/DL) | Standard Deviation 0.264 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Creatinine | 0.008 Milligram per deciliter (MG/DL) | Standard Deviation 0.1072 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Glucose | 6.3 Milligram per deciliter (MG/DL) | Standard Deviation 12.04 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Uric Acid | 5.97 Milligram per deciliter (MG/DL) | Standard Deviation 1.335 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CL (fasting) | -5.8 Milligram per deciliter (MG/DL) | Standard Deviation 7.99 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Calcium | 9.62 Milligram per deciliter (MG/DL) | Standard Deviation 0.458 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Uric Acid | -0.25 Milligram per deciliter (MG/DL) | Standard Deviation 0.176 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Calcium | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.356 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Uric Acid | 0.32 Milligram per deciliter (MG/DL) | Standard Deviation 0.677 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Calcium | -0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.378 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CL (fasting) | -10.2 Milligram per deciliter (MG/DL) | Standard Deviation 15.79 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Uric Acid | 0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.662 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Uric Acid | -0.25 Milligram per deciliter (MG/DL) | Standard Deviation 0.383 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Uric Acid | 0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.327 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Phosphate | 0.08 Milligram per deciliter (MG/DL) | Standard Deviation 0.382 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Uric Acid | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.698 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Uric Acid | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.694 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Uric Acid | -0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.701 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bilirubin | 0.58 Milligram per deciliter (MG/DL) | Standard Deviation 0.422 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Glucose | 7.3 Milligram per deciliter (MG/DL) | Standard Deviation 12.13 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bilirubin | -0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.264 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: TG (fasting) | -18.0 Milligram per deciliter (MG/DL) | Standard Deviation 43.32 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bilirubin | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.121 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: CL (fasting) | 1.3 Milligram per deciliter (MG/DL) | Standard Deviation 19.28 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Glucose | 7.2 Milligram per deciliter (MG/DL) | Standard Deviation 12.56 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bilirubin | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.25 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bilirubin | -0.08 Milligram per deciliter (MG/DL) | Standard Deviation 0.325 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Glucose | 3.7 Milligram per deciliter (MG/DL) | Standard Deviation 7.42 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.343 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: TG (fasting) | -16.5 Milligram per deciliter (MG/DL) | Standard Deviation 32.31 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.2 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CL (fasting) | 0.3 Milligram per deciliter (MG/DL) | Standard Deviation 15.23 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Glucose | 3.8 Milligram per deciliter (MG/DL) | Standard Deviation 9.77 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.21 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CL (fasting) | 2.7 Milligram per deciliter (MG/DL) | Standard Deviation 15.12 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Bilirubin | 0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.105 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Glucose | 92.5 Milligram per deciliter (MG/DL) | Standard Deviation 7.84 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Direct Bilirubin | 0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.082 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: TG (fasting) | -13.7 Milligram per deciliter (MG/DL) | Standard Deviation 50.39 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Direct Bilirubin | -0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.052 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Phosphate | 0.25 Milligram per deciliter (MG/DL) | Standard Deviation 0.217 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Phosphate | -0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.456 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.041 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.041 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: TG (fasting) | -7.3 Milligram per deciliter (MG/DL) | Standard Deviation 26.3 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Phosphate | -0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.331 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.041 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.041 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CL (fasting) | 188.7 Milligram per deciliter (MG/DL) | Standard Deviation 60.01 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Phosphate | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.369 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: TG (fasting) | -18.0 Milligram per deciliter (MG/DL) | Standard Deviation 54.98 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Phosphate | 0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.197 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: BUN | 15.5 Milligram per deciliter (MG/DL) | Standard Deviation 3.89 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: TG (fasting) | 138.5 Milligram per deciliter (MG/DL) | Standard Deviation 58.95 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: BUN | -0.2 Milligram per deciliter (MG/DL) | Standard Deviation 2.64 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Phosphate | 0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.197 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: BUN | -1.2 Milligram per deciliter (MG/DL) | Standard Deviation 4.62 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: TG (fasting) | -18.5 Milligram per deciliter (MG/DL) | Standard Deviation 31.17 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: BUN | 1.3 Milligram per deciliter (MG/DL) | Standard Deviation 3.78 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Phosphate | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.194 |
| RN6G 10 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: BUN | -0.5 Milligram per deciliter (MG/DL) | Standard Deviation 2.74 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Creatinine | 0.042 Milligram per deciliter (MG/DL) | Standard Deviation 0.0891 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: lg M | 101.0 Milligram per deciliter (MG/DL) | Standard Deviation 60.79 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: lg M | 9.7 Milligram per deciliter (MG/DL) | Standard Deviation 8.74 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: lg M | 4.7 Milligram per deciliter (MG/DL) | Standard Deviation 7.06 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: lg M | 8.2 Milligram per deciliter (MG/DL) | Standard Deviation 19.69 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: CL (fasting) | -3.5 Milligram per deciliter (MG/DL) | Standard Deviation 13.88 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: TG (fasting) | 110.5 Milligram per deciliter (MG/DL) | Standard Deviation 41.4 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: TG (fasting) | -9.3 Milligram per deciliter (MG/DL) | Standard Deviation 34.91 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: TG (fasting) | -8.2 Milligram per deciliter (MG/DL) | Standard Deviation 23.51 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: TG (fasting) | -19.7 Milligram per deciliter (MG/DL) | Standard Deviation 18.22 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: TG (fasting) | -2.8 Milligram per deciliter (MG/DL) | Standard Deviation 23.76 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: TG (fasting) | -7.5 Milligram per deciliter (MG/DL) | Standard Deviation 29.13 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: TG (fasting) | -4.2 Milligram per deciliter (MG/DL) | Standard Deviation 24.13 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: TG (fasting) | -13.8 Milligram per deciliter (MG/DL) | Standard Deviation 22.68 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: TG (fasting) | 0.5 Milligram per deciliter (MG/DL) | Standard Deviation 26.94 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: lg G | 840.5 Milligram per deciliter (MG/DL) | Standard Deviation 171.08 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: lg G | 42.7 Milligram per deciliter (MG/DL) | Standard Deviation 26.63 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: lg G | 69.7 Milligram per deciliter (MG/DL) | Standard Deviation 65.83 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: lg G | 41.8 Milligram per deciliter (MG/DL) | Standard Deviation 72.02 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: lg A | 257.3 Milligram per deciliter (MG/DL) | Standard Deviation 108.27 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: lg A | 7.0 Milligram per deciliter (MG/DL) | Standard Deviation 7.55 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: lg A | -10.0 Milligram per deciliter (MG/DL) | Standard Deviation 14.56 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: lg A | -4.2 Milligram per deciliter (MG/DL) | Standard Deviation 26.36 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Calcium | 0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.54 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bilirubin | 0.47 Milligram per deciliter (MG/DL) | Standard Deviation 0.234 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bilirubin | 0.08 Milligram per deciliter (MG/DL) | Standard Deviation 0.435 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bilirubin | 0.25 Milligram per deciliter (MG/DL) | Standard Deviation 0.409 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bilirubin | 0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.133 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bilirubin | 0.20 Milligram per deciliter (MG/DL) | Standard Deviation 0.276 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bilirubin | 0.20 Milligram per deciliter (MG/DL) | Standard Deviation 0.316 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bilirubin | 0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.423 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bilirubin | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.133 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Bilirubin | 0.20 Milligram per deciliter (MG/DL) | Standard Deviation 0.415 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Direct Bilirubin | 0.15 Milligram per deciliter (MG/DL) | Standard Deviation 0.055 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.082 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Direct Bilirubin | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.098 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.063 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.071 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.063 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Direct Bilirubin | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.098 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Direct Bilirubin | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.098 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: BUN | 18.8 Milligram per deciliter (MG/DL) | Standard Deviation 3.87 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: BUN | 0.5 Milligram per deciliter (MG/DL) | Standard Deviation 7.14 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: BUN | 2.7 Milligram per deciliter (MG/DL) | Standard Deviation 1.63 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: BUN | -0.2 Milligram per deciliter (MG/DL) | Standard Deviation 5.98 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: BUN | 1.7 Milligram per deciliter (MG/DL) | Standard Deviation 4.27 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: BUN | 1.3 Milligram per deciliter (MG/DL) | Standard Deviation 2.42 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: BUN | 1.0 Milligram per deciliter (MG/DL) | Standard Deviation 3.46 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: BUN | 0.8 Milligram per deciliter (MG/DL) | Standard Deviation 2.93 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: BUN | 2.3 Milligram per deciliter (MG/DL) | Standard Deviation 4.63 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Creatinine | 0.917 Milligram per deciliter (MG/DL) | Standard Deviation 0.1657 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Creatinine | 0.108 Milligram per deciliter (MG/DL) | Standard Deviation 0.1024 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Creatinine | 0.037 Milligram per deciliter (MG/DL) | Standard Deviation 0.0766 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Creatinine | 0.082 Milligram per deciliter (MG/DL) | Standard Deviation 0.1389 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Creatinine | 0.035 Milligram per deciliter (MG/DL) | Standard Deviation 0.0742 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Creatinine | 0.113 Milligram per deciliter (MG/DL) | Standard Deviation 0.1088 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Creatinine | 0.047 Milligram per deciliter (MG/DL) | Standard Deviation 0.1196 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Creatinine | 0.092 Milligram per deciliter (MG/DL) | Standard Deviation 0.0909 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Uric Acid | 5.77 Milligram per deciliter (MG/DL) | Standard Deviation 1.039 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Calcium | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.387 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Calcium | 0.08 Milligram per deciliter (MG/DL) | Standard Deviation 0.488 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Calcium | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.472 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Uric Acid | 0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.64 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Uric Acid | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.566 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Uric Acid | -0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.943 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Uric Acid | 0.32 Milligram per deciliter (MG/DL) | Standard Deviation 0.804 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Uric Acid | 0.18 Milligram per deciliter (MG/DL) | Standard Deviation 0.828 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Uric Acid | 0.28 Milligram per deciliter (MG/DL) | Standard Deviation 0.422 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Uric Acid | 0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.836 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Uric Acid | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 1.143 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Calcium | 9.60 Milligram per deciliter (MG/DL) | Standard Deviation 0.358 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Calcium | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.395 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CL (fasting) | -12.5 Milligram per deciliter (MG/DL) | Standard Deviation 21.68 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CL (fasting) | -11.8 Milligram per deciliter (MG/DL) | Standard Deviation 24.34 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Calcium | -0.17 Milligram per deciliter (MG/DL) | Standard Deviation 0.327 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Calcium | 0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.509 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Calcium | 0.23 Milligram per deciliter (MG/DL) | Standard Deviation 0.484 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Phosphate | 3.62 Milligram per deciliter (MG/DL) | Standard Deviation 0.637 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Phosphate | 0.18 Milligram per deciliter (MG/DL) | Standard Deviation 0.31 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Phosphate | 0.25 Milligram per deciliter (MG/DL) | Standard Deviation 0.539 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Phosphate | 0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.512 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Phosphate | 0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.356 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Phosphate | -0.27 Milligram per deciliter (MG/DL) | Standard Deviation 0.575 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Phosphate | 0.15 Milligram per deciliter (MG/DL) | Standard Deviation 0.418 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Phosphate | 0.15 Milligram per deciliter (MG/DL) | Standard Deviation 0.521 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Phosphate | 0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.598 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Glucose | 90.0 Milligram per deciliter (MG/DL) | Standard Deviation 13.97 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Glucose | 7.0 Milligram per deciliter (MG/DL) | Standard Deviation 5.48 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Glucose | 6.5 Milligram per deciliter (MG/DL) | Standard Deviation 15.67 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Glucose | 7.5 Milligram per deciliter (MG/DL) | Standard Deviation 11.47 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Glucose | 9.2 Milligram per deciliter (MG/DL) | Standard Deviation 11.58 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Glucose | 17.7 Milligram per deciliter (MG/DL) | Standard Deviation 7.69 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Glucose | 12.5 Milligram per deciliter (MG/DL) | Standard Deviation 14.79 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Glucose | 8.5 Milligram per deciliter (MG/DL) | Standard Deviation 12.85 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Glucose | 3.8 Milligram per deciliter (MG/DL) | Standard Deviation 15.69 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CL (fasting) | 196.5 Milligram per deciliter (MG/DL) | Standard Deviation 48.19 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CL (fasting) | -10.8 Milligram per deciliter (MG/DL) | Standard Deviation 12.63 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CL (fasting) | 1.7 Milligram per deciliter (MG/DL) | Standard Deviation 12.89 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CL (fasting) | -2.2 Milligram per deciliter (MG/DL) | Standard Deviation 10.8 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CL (fasting) | 0.7 Milligram per deciliter (MG/DL) | Standard Deviation 19.05 |
| RN6G 15 mg/kg | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CL (fasting) | 4.2 Milligram per deciliter (MG/DL) | Standard Deviation 10.67 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: BUN | -3.5 Milligram per deciliter (MG/DL) | Standard Deviation 6.35 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Glucose | 20.3 Milligram per deciliter (MG/DL) | Standard Deviation 50.7 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Calcium | -0.08 Milligram per deciliter (MG/DL) | Standard Deviation 0.512 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: BUN | -0.5 Milligram per deciliter (MG/DL) | Standard Deviation 8.87 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: TG (fasting) | -58.0 Milligram per deciliter (MG/DL) | Standard Deviation 77.36 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Calcium | 0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.377 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: BUN | -1.2 Milligram per deciliter (MG/DL) | Standard Deviation 6.76 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: BUN | -1.6 Milligram per deciliter (MG/DL) | Standard Deviation 5.41 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: TG (fasting) | -52.2 Milligram per deciliter (MG/DL) | Standard Deviation 151.28 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Phosphate | 3.28 Milligram per deciliter (MG/DL) | Standard Deviation 0.717 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CL (fasting) | -7.2 Milligram per deciliter (MG/DL) | Standard Deviation 18.86 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Phosphate | 0.22 Milligram per deciliter (MG/DL) | Standard Deviation 0.508 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: BUN | -1.0 Milligram per deciliter (MG/DL) | Standard Deviation 7.62 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: BUN | -3.6 Milligram per deciliter (MG/DL) | Standard Deviation 7.02 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CL (fasting) | 194.2 Milligram per deciliter (MG/DL) | Standard Deviation 33.71 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Phosphate | 0.22 Milligram per deciliter (MG/DL) | Standard Deviation 0.598 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: BUN | 0.0 Milligram per deciliter (MG/DL) | Standard Deviation 4.52 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: BUN | 1.5 Milligram per deciliter (MG/DL) | Standard Deviation 3.73 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: TG (fasting) | -67.6 Milligram per deciliter (MG/DL) | Standard Deviation 84.14 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Phosphate | 0.12 Milligram per deciliter (MG/DL) | Standard Deviation 0.466 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: BUN | 23.3 Milligram per deciliter (MG/DL) | Standard Deviation 8.33 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Direct Bilirubin | 0.03 Milligram per deciliter (MG/DL) | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: TG (fasting) | -89.0 Milligram per deciliter (MG/DL) | Standard Deviation 146.53 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Phosphate | 0.38 Milligram per deciliter (MG/DL) | Standard Deviation 0.497 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.063 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Direct Bilirubin | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.045 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: lg M | -9.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Phosphate | 0.58 Milligram per deciliter (MG/DL) | Standard Deviation 0.554 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Direct Bilirubin | 0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.045 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CL (fasting) | 13.3 Milligram per deciliter (MG/DL) | Standard Deviation 27.09 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Phosphate | 0.36 Milligram per deciliter (MG/DL) | Standard Deviation 0.581 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Direct Bilirubin | 0.00 Milligram per deciliter (MG/DL) | Standard Deviation 0.071 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: TG (fasting) | -98.4 Milligram per deciliter (MG/DL) | Standard Deviation 140.73 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Phosphate | 0.30 Milligram per deciliter (MG/DL) | Standard Deviation 0.863 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Direct Bilirubin | -0.02 Milligram per deciliter (MG/DL) | Standard Deviation 0.041 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: TG (fasting) | -49.5 Milligram per deciliter (MG/DL) | Standard Deviation 124.64 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Phosphate | 0.15 Milligram per deciliter (MG/DL) | Standard Deviation 0.412 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Direct Bilirubin | 0.13 Milligram per deciliter (MG/DL) | Standard Deviation 0.052 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Bilirubin | -0.05 Milligram per deciliter (MG/DL) | Standard Deviation 0.1 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: lg M | -6.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Glucose | 95.8 Milligram per deciliter (MG/DL) | Standard Deviation 9.99 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bilirubin | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.163 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bilirubin | -0.08 Milligram per deciliter (MG/DL) | Standard Deviation 0.192 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CL (fasting) | 8.0 Milligram per deciliter (MG/DL) | Standard Deviation 42.82 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Glucose | 3.3 Milligram per deciliter (MG/DL) | Standard Deviation 14.39 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bilirubin | -0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.158 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bilirubin | -0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.158 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: TG (fasting) | -8.0 Milligram per deciliter (MG/DL) | Standard Deviation 37.31 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Glucose | 0.5 Milligram per deciliter (MG/DL) | Standard Deviation 11.04 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bilirubin | -0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.122 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bilirubin | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.121 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: TG (fasting) | 195.2 Milligram per deciliter (MG/DL) | Standard Deviation 149.85 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Glucose | 7.8 Milligram per deciliter (MG/DL) | Standard Deviation 13.35 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bilirubin | -0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.126 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bilirubin | 0.52 Milligram per deciliter (MG/DL) | Standard Deviation 0.204 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: lg M | 58.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Glucose | 3.6 Milligram per deciliter (MG/DL) | Standard Deviation 10.67 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Calcium | -0.37 Milligram per deciliter (MG/DL) | Standard Deviation 0.301 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: lg A | -25.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CL (fasting) | -2.4 Milligram per deciliter (MG/DL) | Standard Deviation 23.2 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Glucose | 11.0 Milligram per deciliter (MG/DL) | Standard Deviation 14.61 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: lg A | 299.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: lg G | -40.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Uric Acid | 0.32 Milligram per deciliter (MG/DL) | Standard Deviation 0.785 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Uric Acid | 0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.997 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Uric Acid | -0.48 Milligram per deciliter (MG/DL) | Standard Deviation 0.487 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: CL (fasting) | -1.3 Milligram per deciliter (MG/DL) | Standard Deviation 29.34 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Uric Acid | 0.22 Milligram per deciliter (MG/DL) | Standard Deviation 0.779 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Uric Acid | -0.07 Milligram per deciliter (MG/DL) | Standard Deviation 0.463 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Uric Acid | 0.22 Milligram per deciliter (MG/DL) | Standard Deviation 0.471 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Glucose | 17.6 Milligram per deciliter (MG/DL) | Standard Deviation 32.65 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Uric Acid | 0.48 Milligram per deciliter (MG/DL) | Standard Deviation 0.933 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Calcium | -0.26 Milligram per deciliter (MG/DL) | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: lg G | -30.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Uric Acid | -0.10 Milligram per deciliter (MG/DL) | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Calcium | -0.38 Milligram per deciliter (MG/DL) | Standard Deviation 0.396 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Uric Acid | 5.58 Milligram per deciliter (MG/DL) | Standard Deviation 1.238 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: lg G | 793.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Calcium | 9.76 Milligram per deciliter (MG/DL) | Standard Deviation 0.301 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Creatinine | -0.045 Milligram per deciliter (MG/DL) | Standard Deviation 0.3023 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Creatinine | 0.015 Milligram per deciliter (MG/DL) | Standard Deviation 0.2118 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CL (fasting) | 7.2 Milligram per deciliter (MG/DL) | Standard Deviation 40.49 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Creatinine | -0.018 Milligram per deciliter (MG/DL) | Standard Deviation 0.2525 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Calcium | -0.22 Milligram per deciliter (MG/DL) | Standard Deviation 0.471 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Creatinine | 0.002 Milligram per deciliter (MG/DL) | Standard Deviation 0.1956 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Glucose | 7.2 Milligram per deciliter (MG/DL) | Standard Deviation 28.03 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CL (fasting) | 13.0 Milligram per deciliter (MG/DL) | Standard Deviation 37.9 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Creatinine | -0.024 Milligram per deciliter (MG/DL) | Standard Deviation 0.1747 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Creatinine | -0.038 Milligram per deciliter (MG/DL) | Standard Deviation 0.1512 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: TG (fasting) | -42.0 Milligram per deciliter (MG/DL) | Standard Deviation 168.16 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: lg A | -25.0 Milligram per deciliter (MG/DL) | — |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Calcium | -0.16 Milligram per deciliter (MG/DL) | Standard Deviation 0.498 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Creatinine | -0.013 Milligram per deciliter (MG/DL) | Standard Deviation 0.1317 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Creatinine | -0.007 Milligram per deciliter (MG/DL) | Standard Deviation 0.1371 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CL (fasting) | -5.4 Milligram per deciliter (MG/DL) | Standard Deviation 33.06 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Calcium | -0.30 Milligram per deciliter (MG/DL) | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Creatinine | 1.105 Milligram per deciliter (MG/DL) | Standard Deviation 0.3136 |
Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Time frame: Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112 | -1.78 Beats per minute | Standard Deviation 1.559 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140 | 0.50 Beats per minute | Standard Deviation 2.606 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 2.28 Beats per minute | Standard Deviation 2.752 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140 | 3.67 Beats per minute | Standard Deviation 5.578 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 2.61 Beats per minute | Standard Deviation 11.432 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET | -0.61 Beats per minute | Standard Deviation 5.031 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28 | -1.78 Beats per minute | Standard Deviation 2.562 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1 | -0.33 Beats per minute | Standard Deviation 3.026 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56 | 0.39 Beats per minute | Standard Deviation 4.096 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168 | 2.22 Beats per minute | Standard Deviation 5.419 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84 | 0.22 Beats per minute | Standard Deviation 3.41 |
| RN6G 5 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline | 64.94 Beats per minute | Standard Deviation 9.318 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline | 63.17 Beats per minute | Standard Deviation 7.327 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28 | -0.17 Beats per minute | Standard Deviation 3.475 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET | -0.67 Beats per minute | Standard Deviation 4.279 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140 | 5.11 Beats per minute | Standard Deviation 6.869 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112 | 1.33 Beats per minute | Standard Deviation 4.58 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140 | 2.89 Beats per minute | Standard Deviation 5.556 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168 | 2.00 Beats per minute | Standard Deviation 1.687 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84 | 0.50 Beats per minute | Standard Deviation 3.378 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56 | 1.17 Beats per minute | Standard Deviation 1.81 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 1.17 Beats per minute | Standard Deviation 3.65 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 2.11 Beats per minute | Standard Deviation 5.188 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET | -2.50 Beats per minute | Standard Deviation 4.451 |
| RN6G 10 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1 | -1.67 Beats per minute | Standard Deviation 4.142 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140 | -3.61 Beats per minute | Standard Deviation 5.752 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline | 66.06 Beats per minute | Standard Deviation 7.295 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1 | -5.44 Beats per minute | Standard Deviation 6.527 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | -1.72 Beats per minute | Standard Deviation 8.045 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28 | -4.39 Beats per minute | Standard Deviation 5.463 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56 | -4.89 Beats per minute | Standard Deviation 7.29 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84 | -3.72 Beats per minute | Standard Deviation 6.191 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112 | -1.89 Beats per minute | Standard Deviation 3.959 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140 | -1.39 Beats per minute | Standard Deviation 6.591 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | -5.22 Beats per minute | Standard Deviation 6.649 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168 | -3.56 Beats per minute | Standard Deviation 7.745 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET | 1.11 Beats per minute | Standard Deviation 7.067 |
| RN6G 15 mg/kg | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET | 0.94 Beats per minute | Standard Deviation 6.22 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84 | 4.00 Beats per minute | Standard Deviation 12.243 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140 | 0.47 Beats per minute | Standard Deviation 12.613 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56 | -1.11 Beats per minute | Standard Deviation 4.617 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28 | -3.78 Beats per minute | Standard Deviation 5.496 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline | 65.44 Beats per minute | Standard Deviation 7.556 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168 | 2.20 Beats per minute | Standard Deviation 5.316 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 4.00 Beats per minute | Standard Deviation 7.226 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1 | 2.72 Beats per minute | Standard Deviation 10.603 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET | 3.08 Beats per minute | Standard Deviation 9.094 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET | -3.44 Beats per minute | Standard Deviation 5.73 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | -2.13 Beats per minute | Standard Deviation 10.038 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140 | 0.93 Beats per minute | Standard Deviation 3.919 |
| Placebo | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112 | 3.00 Beats per minute | Standard Deviation 6.342 |
Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Following parameters were analyzed for laboratory examination: Aspartate Aminotransferase (AMT), Creatine Kinase (CK), Alanine Aminotransferase (ALT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD), Alkaline Phosphatase (AP).
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AST | -3.3 international units per liter (IU/L) | Standard Deviation 4.27 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CK | -0.5 international units per liter (IU/L) | Standard Deviation 79.89 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CK | -15.3 international units per liter (IU/L) | Standard Deviation 12.6 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: ALT | -2.0 international units per liter (IU/L) | Standard Deviation 4.52 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CK | -32.5 international units per liter (IU/L) | Standard Deviation 34.16 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CK | -16.7 international units per liter (IU/L) | Standard Deviation 28.79 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: LD | -3.0 international units per liter (IU/L) | Standard Deviation 30.42 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: ALT | -3.0 international units per liter (IU/L) | Standard Deviation 4.15 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CK | -29.3 international units per liter (IU/L) | Standard Deviation 24.47 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: GGT | -3.3 international units per liter (IU/L) | Standard Deviation 3.33 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CK | 15.0 international units per liter (IU/L) | Standard Deviation 43.26 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AP | 63.5 international units per liter (IU/L) | Standard Deviation 20.34 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: ALT | 8.2 international units per liter (IU/L) | Standard Deviation 25.13 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: ALT | 17.0 international units per liter (IU/L) | Standard Deviation 4 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: ALT | -1.8 international units per liter (IU/L) | Standard Deviation 4.07 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: ALT | -0.3 international units per liter (IU/L) | Standard Deviation 5.13 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: ALT | 1.8 international units per liter (IU/L) | Standard Deviation 3.54 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AP | -1.3 international units per liter (IU/L) | Standard Deviation 3.72 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: LD | -11.3 international units per liter (IU/L) | Standard Deviation 9.4 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: GGT | -5.0 international units per liter (IU/L) | Standard Deviation 4.52 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AP | -2.3 international units per liter (IU/L) | Standard Deviation 6.56 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AP | -2.3 international units per liter (IU/L) | Standard Deviation 8.62 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AST | 0.2 international units per liter (IU/L) | Standard Deviation 5.81 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: GGT | -4.5 international units per liter (IU/L) | Standard Deviation 5.01 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AP | -1.7 international units per liter (IU/L) | Standard Deviation 7.17 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: LD | -15.7 international units per liter (IU/L) | Standard Deviation 13.06 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AP | -1.0 international units per liter (IU/L) | Standard Deviation 12.12 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: LD | -18.0 international units per liter (IU/L) | Standard Deviation 6.9 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: GGT | -2.2 international units per liter (IU/L) | Standard Deviation 6.88 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AP | -1.3 international units per liter (IU/L) | Standard Deviation 8.36 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AST | 22.2 international units per liter (IU/L) | Standard Deviation 3.13 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AST | -1.2 international units per liter (IU/L) | Standard Deviation 8.16 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: GGT | -2.0 international units per liter (IU/L) | Standard Deviation 4.05 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AST | 1.3 international units per liter (IU/L) | Standard Deviation 3.93 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: LD | -17.3 international units per liter (IU/L) | Standard Deviation 9.65 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AST | -3.5 international units per liter (IU/L) | Standard Deviation 2.95 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AST | -3.2 international units per liter (IU/L) | Standard Deviation 2.64 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: ALT | 1.0 international units per liter (IU/L) | Standard Deviation 3.69 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: GGT | -2.3 international units per liter (IU/L) | Standard Deviation 3.39 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AST | 0.3 international units per liter (IU/L) | Standard Deviation 4.18 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: LD | 174.5 international units per liter (IU/L) | Standard Deviation 13.4 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: LD | -7.5 international units per liter (IU/L) | Standard Deviation 18.56 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: GGT | -2.7 international units per liter (IU/L) | Standard Deviation 2.58 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CK | 97.2 international units per liter (IU/L) | Standard Deviation 40.32 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AP | 3.3 international units per liter (IU/L) | Standard Deviation 9.95 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: GGT | 22.0 international units per liter (IU/L) | Standard Deviation 6.78 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: LD | 5.7 international units per liter (IU/L) | Standard Deviation 27.16 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CK | -26.3 international units per liter (IU/L) | Standard Deviation 26.07 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: LD | -6.5 international units per liter (IU/L) | Standard Deviation 17.56 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: LD | -6.0 international units per liter (IU/L) | Standard Deviation 13.11 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AP | -0.5 international units per liter (IU/L) | Standard Deviation 10.84 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: AP | -5.8 international units per liter (IU/L) | Standard Deviation 14.8 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: GGT | -0.8 international units per liter (IU/L) | Standard Deviation 4.75 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AST | -0.7 international units per liter (IU/L) | Standard Deviation 4.27 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AP | -6.5 international units per liter (IU/L) | Standard Deviation 10.8 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AST | -0.5 international units per liter (IU/L) | Standard Deviation 2.35 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CK | -4.2 international units per liter (IU/L) | Standard Deviation 12.48 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AST | 2.0 international units per liter (IU/L) | Standard Deviation 1.67 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: ALT | -1.2 international units per liter (IU/L) | Standard Deviation 3.54 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: GGT | -0.3 international units per liter (IU/L) | Standard Deviation 3.93 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CK | 1.0 international units per liter (IU/L) | Standard Deviation 18.22 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: GGT | -1.5 international units per liter (IU/L) | Standard Deviation 3.39 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: AST | -0.5 international units per liter (IU/L) | Standard Deviation 1.87 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AP | -4.2 international units per liter (IU/L) | Standard Deviation 10.61 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CK | 7.5 international units per liter (IU/L) | Standard Deviation 18.73 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: LD | -5.2 international units per liter (IU/L) | Standard Deviation 15.56 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: ALT | -1.8 international units per liter (IU/L) | Standard Deviation 3.49 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: LD | 0.0 international units per liter (IU/L) | Standard Deviation 17.42 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CK | 7.7 international units per liter (IU/L) | Standard Deviation 19.71 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: ALT | 0.3 international units per liter (IU/L) | Standard Deviation 1.97 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AST | 21.2 international units per liter (IU/L) | Standard Deviation 1.6 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: LD | -10.0 international units per liter (IU/L) | Standard Deviation 7.69 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CK | 16.3 international units per liter (IU/L) | Standard Deviation 45.35 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: GGT | -0.7 international units per liter (IU/L) | Standard Deviation 2.34 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: ALT | 2.2 international units per liter (IU/L) | Standard Deviation 2.48 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: GGT | -2.3 international units per liter (IU/L) | Standard Deviation 4.32 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CK | 19.0 international units per liter (IU/L) | Standard Deviation 29.14 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AST | -1.0 international units per liter (IU/L) | Standard Deviation 1.41 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: LD | 174.7 international units per liter (IU/L) | Standard Deviation 25.11 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: CK | 61.8 international units per liter (IU/L) | Standard Deviation 134 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AP | 72.5 international units per liter (IU/L) | Standard Deviation 22.65 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: ALT | -1.2 international units per liter (IU/L) | Standard Deviation 2.4 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CK | 0.7 international units per liter (IU/L) | Standard Deviation 15.06 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: ALT | 19.5 international units per liter (IU/L) | Standard Deviation 1.64 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: LD | -14.5 international units per liter (IU/L) | Standard Deviation 9.89 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CK | 104.8 international units per liter (IU/L) | Standard Deviation 74.79 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AST | 0.0 international units per liter (IU/L) | Standard Deviation 0.89 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: ALT | 0.3 international units per liter (IU/L) | Standard Deviation 2.66 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: GGT | -2.3 international units per liter (IU/L) | Standard Deviation 5.01 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: ALT | 0.8 international units per liter (IU/L) | Standard Deviation 1.6 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: GGT | 21.5 international units per liter (IU/L) | Standard Deviation 8.29 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: GGT | -1.3 international units per liter (IU/L) | Standard Deviation 3.27 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AP | -4.0 international units per liter (IU/L) | Standard Deviation 4.43 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: ALT | -1.0 international units per liter (IU/L) | Standard Deviation 3.46 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AST | -0.2 international units per liter (IU/L) | Standard Deviation 2.48 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: LD | -14.0 international units per liter (IU/L) | Standard Deviation 21.95 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AP | -4.7 international units per liter (IU/L) | Standard Deviation 3.98 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: LD | -3.5 international units per liter (IU/L) | Standard Deviation 17.93 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: GGT | -2.2 international units per liter (IU/L) | Standard Deviation 4.71 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AP | -6.0 international units per liter (IU/L) | Standard Deviation 9.32 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AP | -0.8 international units per liter (IU/L) | Standard Deviation 6.31 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AST | -0.3 international units per liter (IU/L) | Standard Deviation 3.14 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: GGT | -1.2 international units per liter (IU/L) | Standard Deviation 2.48 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AST | -5.8 international units per liter (IU/L) | Standard Deviation 11.61 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AST | -5.2 international units per liter (IU/L) | Standard Deviation 9.58 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: LD | -1.7 international units per liter (IU/L) | Standard Deviation 13.69 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: LD | -0.8 international units per liter (IU/L) | Standard Deviation 12.72 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: LD | -1.0 international units per liter (IU/L) | Standard Deviation 15.48 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: LD | -2.8 international units per liter (IU/L) | Standard Deviation 13.51 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: LD | 4.8 international units per liter (IU/L) | Standard Deviation 18.63 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: LD | 7.2 international units per liter (IU/L) | Standard Deviation 19.22 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AP | 59.3 international units per liter (IU/L) | Standard Deviation 12.72 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AP | -6.8 international units per liter (IU/L) | Standard Deviation 2.5 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AP | -5.3 international units per liter (IU/L) | Standard Deviation 9.87 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AP | -7.7 international units per liter (IU/L) | Standard Deviation 9.67 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AP | -6.5 international units per liter (IU/L) | Standard Deviation 8.24 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AP | -6.5 international units per liter (IU/L) | Standard Deviation 8.98 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AP | -5.8 international units per liter (IU/L) | Standard Deviation 11.25 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AST | 25.5 international units per liter (IU/L) | Standard Deviation 11.38 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AST | -6.8 international units per liter (IU/L) | Standard Deviation 12.26 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AST | -3.7 international units per liter (IU/L) | Standard Deviation 10.05 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AST | -4.3 international units per liter (IU/L) | Standard Deviation 11.02 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AST | -6.2 international units per liter (IU/L) | Standard Deviation 9.26 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AST | -3.8 international units per liter (IU/L) | Standard Deviation 11.34 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: AST | -3.8 international units per liter (IU/L) | Standard Deviation 9.77 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AP | -6.2 international units per liter (IU/L) | Standard Deviation 10.94 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: AP | -3.3 international units per liter (IU/L) | Standard Deviation 11.52 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: LD | -1.2 international units per liter (IU/L) | Standard Deviation 13.51 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CK | 80.0 international units per liter (IU/L) | Standard Deviation 20.21 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CK | -7.3 international units per liter (IU/L) | Standard Deviation 24.1 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CK | 12.0 international units per liter (IU/L) | Standard Deviation 11.45 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CK | 7.5 international units per liter (IU/L) | Standard Deviation 26.77 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CK | 2.8 international units per liter (IU/L) | Standard Deviation 13.1 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CK | 0.5 international units per liter (IU/L) | Standard Deviation 29.92 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CK | 21.7 international units per liter (IU/L) | Standard Deviation 59.27 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CK | 77.8 international units per liter (IU/L) | Standard Deviation 148.91 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: CK | 19.0 international units per liter (IU/L) | Standard Deviation 31.69 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: ALT | 24.3 international units per liter (IU/L) | Standard Deviation 14.14 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: ALT | -11.3 international units per liter (IU/L) | Standard Deviation 14.24 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: ALT | -6.2 international units per liter (IU/L) | Standard Deviation 13.7 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: ALT | -6.8 international units per liter (IU/L) | Standard Deviation 14.13 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: ALT | -7.2 international units per liter (IU/L) | Standard Deviation 14.5 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: ALT | -6.5 international units per liter (IU/L) | Standard Deviation 10.54 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: ALT | -8.7 international units per liter (IU/L) | Standard Deviation 13.81 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: ALT | -6.7 international units per liter (IU/L) | Standard Deviation 13.28 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: ALT | -6.8 international units per liter (IU/L) | Standard Deviation 12.8 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: GGT | 17.3 international units per liter (IU/L) | Standard Deviation 7.37 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: GGT | -1.8 international units per liter (IU/L) | Standard Deviation 2.06 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: GGT | 0.5 international units per liter (IU/L) | Standard Deviation 2.59 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: GGT | -0.7 international units per liter (IU/L) | Standard Deviation 4.8 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: GGT | -0.2 international units per liter (IU/L) | Standard Deviation 2.04 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: GGT | -1.3 international units per liter (IU/L) | Standard Deviation 2.73 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: GGT | 0.2 international units per liter (IU/L) | Standard Deviation 2.56 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: GGT | 0.5 international units per liter (IU/L) | Standard Deviation 1.97 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: LD | 166.7 international units per liter (IU/L) | Standard Deviation 19.65 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: LD | -8.0 international units per liter (IU/L) | Standard Deviation 15.47 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: LD | 0.2 international units per liter (IU/L) | Standard Deviation 18.35 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: ALT | 0.8 international units per liter (IU/L) | Standard Deviation 4.55 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: CK | 9.2 international units per liter (IU/L) | Standard Deviation 18.69 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: CK | 67.5 international units per liter (IU/L) | Standard Deviation 26.91 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: LD | -4.3 international units per liter (IU/L) | Standard Deviation 20.26 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: ALT | 0.3 international units per liter (IU/L) | Standard Deviation 3.44 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: AP | 9.3 international units per liter (IU/L) | Standard Deviation 18.71 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: GGT | 31.5 international units per liter (IU/L) | Standard Deviation 61.07 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: ALT | 13.8 international units per liter (IU/L) | Standard Deviation 25.33 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AP | 8.8 international units per liter (IU/L) | Standard Deviation 9.45 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AP | 3.4 international units per liter (IU/L) | Standard Deviation 5.55 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: LD | -1.2 international units per liter (IU/L) | Standard Deviation 16.57 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: GGT | 20.0 international units per liter (IU/L) | Standard Deviation 10.32 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: AST | 7.5 international units per liter (IU/L) | Standard Deviation 10.47 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: AST | 1.8 international units per liter (IU/L) | Standard Deviation 2.64 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: LD | -6.0 international units per liter (IU/L) | Standard Deviation 15.87 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: GGT | -0.7 international units per liter (IU/L) | Standard Deviation 1.21 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: AST | 0.6 international units per liter (IU/L) | Standard Deviation 3.65 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AST | 2.5 international units per liter (IU/L) | Standard Deviation 7.79 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AST | -1.0 international units per liter (IU/L) | Standard Deviation 4.64 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: GGT | -0.8 international units per liter (IU/L) | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AST | -1.3 international units per liter (IU/L) | Standard Deviation 3.2 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AST | 19.5 international units per liter (IU/L) | Standard Deviation 4.55 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: LD | 172.0 international units per liter (IU/L) | Standard Deviation 20.03 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: GGT | -2.0 international units per liter (IU/L) | Standard Deviation 4.12 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: AP | 1.4 international units per liter (IU/L) | Standard Deviation 4.51 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AP | 5.8 international units per liter (IU/L) | Standard Deviation 5.12 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AST | -0.8 international units per liter (IU/L) | Standard Deviation 3.86 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: GGT | -1.0 international units per liter (IU/L) | Standard Deviation 3.39 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: AP | 0.2 international units per liter (IU/L) | Standard Deviation 5.89 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: AP | -0.8 international units per liter (IU/L) | Standard Deviation 3.31 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: LD | 3.3 international units per liter (IU/L) | Standard Deviation 25.53 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: GGT | 0.0 international units per liter (IU/L) | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: AP | -1.7 international units per liter (IU/L) | Standard Deviation 3.78 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: AP | 69.7 international units per liter (IU/L) | Standard Deviation 9.73 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: LD | 1.2 international units per liter (IU/L) | Standard Deviation 8.53 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: GGT | 0.8 international units per liter (IU/L) | Standard Deviation 1.92 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: ALT | -0.2 international units per liter (IU/L) | Standard Deviation 0.98 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: LD | -6.5 international units per liter (IU/L) | Standard Deviation 38.66 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: ALT | 3.3 international units per liter (IU/L) | Standard Deviation 11.24 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: ALT | 17.2 international units per liter (IU/L) | Standard Deviation 5.27 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: CK | 9.5 international units per liter (IU/L) | Standard Deviation 8.58 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: LD | -4.0 international units per liter (IU/L) | Standard Deviation 18.61 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: ALT | -2.5 international units per liter (IU/L) | Standard Deviation 3.32 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: CK | 7.5 international units per liter (IU/L) | Standard Deviation 9.79 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: CK | 8.8 international units per liter (IU/L) | Standard Deviation 16.16 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: AST | -2.2 international units per liter (IU/L) | Standard Deviation 2.77 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: ALT | -2.2 international units per liter (IU/L) | Standard Deviation 3.96 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: CK | 53.0 international units per liter (IU/L) | Standard Deviation 106.5 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: CK | -2.0 international units per liter (IU/L) | Standard Deviation 19.79 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: GGT | 1.3 international units per liter (IU/L) | Standard Deviation 3.98 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: ALT | -1.0 international units per liter (IU/L) | Standard Deviation 4.06 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: CK | 3.2 international units per liter (IU/L) | Standard Deviation 14.2 |
| Placebo | Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: CK | 8.7 international units per liter (IU/L) | Standard Deviation 15.6 |
Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140
Time frame: Baseline, Day 28, 56, 84, 112, 140
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: IL-6 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: beta IL-1 | 0.32 Picogram per milliliter (pg/ml) | Standard Deviation 0.776 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: IL-6 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: beta IL-1 | 0.23 Picogram per milliliter (pg/ml) | Standard Deviation 0.572 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: IL-6 | 1.84 Picogram per milliliter (pg/ml) | Standard Deviation 2.855 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: beta IL-1 | 0.40 Picogram per milliliter (pg/ml) | Standard Deviation 0.98 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: IL-6 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: alpha TNF | 2.943 Picogram per milliliter (pg/ml) | Standard Deviation 1.7942 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: alpha TNF | 1.175 Picogram per milliliter (pg/ml) | Standard Deviation 2.017 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: alpha TNF | 0.590 Picogram per milliliter (pg/ml) | Standard Deviation 2.2536 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: alpha TNF | 1.423 Picogram per milliliter (pg/ml) | Standard Deviation 1.2367 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: IL-6 | 0.90 Picogram per milliliter (pg/ml) | Standard Deviation 1.445 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: alpha TNF | 1.762 Picogram per milliliter (pg/ml) | Standard Deviation 1.5999 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: alpha TNF | 1.512 Picogram per milliliter (pg/ml) | Standard Deviation 1.4736 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: IL-6 | 0.67 Picogram per milliliter (pg/ml) | Standard Deviation 1.633 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: IL-6 | 1.22 Picogram per milliliter (pg/ml) | Standard Deviation 1.354 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: IL-6 | 0.90 Picogram per milliliter (pg/ml) | Standard Deviation 3.366 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: IL-6 | -0.05 Picogram per milliliter (pg/ml) | Standard Deviation 2.002 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: IL-6 | -1.22 Picogram per milliliter (pg/ml) | Standard Deviation 1.354 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: IL-6 | 1.50 Picogram per milliliter (pg/ml) | Standard Deviation 2.386 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: IL-6 | -1.22 Picogram per milliliter (pg/ml) | Standard Deviation 1.354 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: IL-6 | 0.10 Picogram per milliliter (pg/ml) | Standard Deviation 3.186 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: IL-6 | 1.23 Picogram per milliliter (pg/ml) | Standard Deviation 4.19 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: IL-6 | 0.62 Picogram per milliliter (pg/ml) | Standard Deviation 1.511 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: IL-6 | 3.38 Picogram per milliliter (pg/ml) | Standard Deviation 5.754 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: IL-6 | -0.05 Picogram per milliliter (pg/ml) | Standard Deviation 2.247 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: IL-6 | -0.62 Picogram per milliliter (pg/ml) | Standard Deviation 1.511 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: beta IL-1 | 0.00 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: IL-6 | 0.52 Picogram per milliliter (pg/ml) | Standard Deviation 1.163 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: IL-6 | 0.34 Picogram per milliliter (pg/ml) | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: IL-6 | 0.20 Picogram per milliliter (pg/ml) | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: IL-6 | 0.50 Picogram per milliliter (pg/ml) | Standard Deviation 1 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: IL-6 | 0.55 Picogram per milliliter (pg/ml) | Standard Deviation 1.168 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: IL-6 | 1.63 Picogram per milliliter (pg/ml) | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: alpha TNF | 3.185 Picogram per milliliter (pg/ml) | Standard Deviation 1.2657 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: alpha TNF | -1.425 Picogram per milliliter (pg/ml) | Standard Deviation 1.2233 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: alpha TNF | 0.790 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: alpha TNF | 0.520 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: alpha TNF | 1.140 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 140: alpha TNF | 1.220 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Baseline: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 28: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 56: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 84: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | Change at Day 112: INF (Gamma) | 0.0 Picogram per milliliter (pg/ml) | — |
Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140
Time frame: Baseline, Day 28, 56, 84, 112, 140
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Baseline: C4D | 2.692 Microgram per milliliter (mcg/mL) | Standard Deviation 1.5264 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 28: C4D | 1.078 Microgram per milliliter (mcg/mL) | Standard Deviation 4.3643 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 56: C4D | -1.503 Microgram per milliliter (mcg/mL) | Standard Deviation 1.4911 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 84: C4D | -0.907 Microgram per milliliter (mcg/mL) | Standard Deviation 1.6772 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 112: C4D | -0.466 Microgram per milliliter (mcg/mL) | Standard Deviation 1.6322 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 140: C4D | -0.338 Microgram per milliliter (mcg/mL) | Standard Deviation 1.679 |
| Placebo | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 112: C4D | 1.060 Microgram per milliliter (mcg/mL) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Baseline: C4D | 3.720 Microgram per milliliter (mcg/mL) | Standard Deviation 2.291 |
| Placebo | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 84: C4D | 1.180 Microgram per milliliter (mcg/mL) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 28: C4D | -1.720 Microgram per milliliter (mcg/mL) | Standard Deviation 1.0748 |
| Placebo | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 140: C4D | 0.140 Microgram per milliliter (mcg/mL) | — |
| Placebo | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | Change at Day 56: C4D | -1.320 Microgram per milliliter (mcg/mL) | — |
Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140
Time frame: Baseline, Day 28, 56, 84, 112, 140
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C5B-9 | -9.8 Nanogram per milliliter (ng/mL) | Standard Deviation 152.15 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C5B-9 | -36.8 Nanogram per milliliter (ng/mL) | Standard Deviation 69.42 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C5B-9 | -33.5 Nanogram per milliliter (ng/mL) | Standard Deviation 83.69 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C3A | 970.3 Nanogram per milliliter (ng/mL) | Standard Deviation 214.77 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C5B-9 | -78.0 Nanogram per milliliter (ng/mL) | Standard Deviation 47.76 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C3A ) | 404.7 Nanogram per milliliter (ng/mL) | Standard Deviation 280.7 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C3A | 380.3 Nanogram per milliliter (ng/mL) | Standard Deviation 341.07 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C3A | 560.2 Nanogram per milliliter (ng/mL) | Standard Deviation 1109.51 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C5B-9 | -35.8 Nanogram per milliliter (ng/mL) | Standard Deviation 63.01 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C3A | 445.2 Nanogram per milliliter (ng/mL) | Standard Deviation 465.87 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C3A | 297.8 Nanogram per milliliter (ng/mL) | Standard Deviation 508.62 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C5B-9 | 289.5 Nanogram per milliliter (ng/mL) | Standard Deviation 56.64 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C3A | 447.5 Nanogram per milliliter (ng/mL) | Standard Deviation 457.21 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C5B-9 | 199.8 Nanogram per milliliter (ng/mL) | Standard Deviation 16.87 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C3A | 290.2 Nanogram per milliliter (ng/mL) | Standard Deviation 414.07 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C5B-9 | 11.3 Nanogram per milliliter (ng/mL) | Standard Deviation 59.09 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C5B-9 | 16.6 Nanogram per milliliter (ng/mL) | Standard Deviation 105.2 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C5B-9 | -26.2 Nanogram per milliliter (ng/mL) | Standard Deviation 44.51 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C3A | 928.0 Nanogram per milliliter (ng/mL) | Standard Deviation 228.37 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C3A | 928.6 Nanogram per milliliter (ng/mL) | Standard Deviation 398.79 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C3A | 246.0 Nanogram per milliliter (ng/mL) | Standard Deviation 337.86 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C3A ) | 221.0 Nanogram per milliliter (ng/mL) | Standard Deviation 202.67 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C5B-9 | -10.2 Nanogram per milliliter (ng/mL) | Standard Deviation 123.29 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C5B-9 | -15.3 Nanogram per milliliter (ng/mL) | Standard Deviation 36.68 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C5B-9 | -63.0 Nanogram per milliliter (ng/mL) | Standard Deviation 131.56 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C3A | 1465.8 Nanogram per milliliter (ng/mL) | Standard Deviation 352.95 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C3A | 161.3 Nanogram per milliliter (ng/mL) | Standard Deviation 523.83 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C3A ) | -74.5 Nanogram per milliliter (ng/mL) | Standard Deviation 723.41 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C3A | -610.3 Nanogram per milliliter (ng/mL) | Standard Deviation 425.31 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C3A | -129.5 Nanogram per milliliter (ng/mL) | Standard Deviation 454.93 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C3A | -68.3 Nanogram per milliliter (ng/mL) | Standard Deviation 543.15 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C5B-9 | 244.3 Nanogram per milliliter (ng/mL) | Standard Deviation 132.87 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C5B-9 | 0.0 Nanogram per milliliter (ng/mL) | Standard Deviation 50.73 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C5B-9 | 34.5 Nanogram per milliliter (ng/mL) | Standard Deviation 102.8 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C5B-9 | 51.8 Nanogram per milliliter (ng/mL) | Standard Deviation 106.84 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C5B-9 | -13.3 Nanogram per milliliter (ng/mL) | Standard Deviation 98.95 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C3A | -32.2 Nanogram per milliliter (ng/mL) | Standard Deviation 846.33 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C3A | 746.2 Nanogram per milliliter (ng/mL) | Standard Deviation 1686.03 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C3A | 1813.0 Nanogram per milliliter (ng/mL) | Standard Deviation 1060.66 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C5B-9 | 4.8 Nanogram per milliliter (ng/mL) | Standard Deviation 86.14 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 84: C3A | 117.0 Nanogram per milliliter (ng/mL) | Standard Deviation 826.44 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C3A ) | -220.6 Nanogram per milliliter (ng/mL) | Standard Deviation 231.43 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 140: C5B-9 | -30.2 Nanogram per milliliter (ng/mL) | Standard Deviation 74.25 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 112: C5B-9 | 42.6 Nanogram per milliliter (ng/mL) | Standard Deviation 99.64 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C5B-9 | -85.5 Nanogram per milliliter (ng/mL) | Standard Deviation 87.54 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Baseline: C5B-9 | 299.7 Nanogram per milliliter (ng/mL) | Standard Deviation 154.14 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 28: C3A | -305.3 Nanogram per milliliter (ng/mL) | Standard Deviation 899.05 |
| Placebo | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | Change at Day 56: C5B-9 | -8.0 Nanogram per milliliter (ng/mL) | Standard Deviation 109.9 |
Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Following hematology parameters were analyzed for laboratory examination: Hemoglobin, Hematocrit, Red blood cell (RBC) count, Platelet count, WBC count, Total neutrophils (Abs),Eosinophils (Abs),Monocytes (Abs),Basophils (Abs), Lymphocytes (Abs).
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hematocrit | -0.25 Percentage of RBCs to total blood volume | Standard Deviation 1.545 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hematocrit | -1.47 Percentage of RBCs to total blood volume | Standard Deviation 1.48 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hematocrit | 0.07 Percentage of RBCs to total blood volume | Standard Deviation 2.272 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hematocrit | -0.53 Percentage of RBCs to total blood volume | Standard Deviation 1.458 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hematocrit | -1.18 Percentage of RBCs to total blood volume | Standard Deviation 1.161 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hematocrit | -0.30 Percentage of RBCs to total blood volume | Standard Deviation 1.611 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hematocrit | -0.60 Percentage of RBCs to total blood volume | Standard Deviation 1.797 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hematocrit | 41.70 Percentage of RBCs to total blood volume | Standard Deviation 3.906 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hematocrit | 0.08 Percentage of RBCs to total blood volume | Standard Deviation 2.464 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hematocrit | 41.28 Percentage of RBCs to total blood volume | Standard Deviation 2.436 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hematocrit | -0.67 Percentage of RBCs to total blood volume | Standard Deviation 0.864 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hematocrit | -1.68 Percentage of RBCs to total blood volume | Standard Deviation 0.823 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hematocrit | 0.56 Percentage of RBCs to total blood volume | Standard Deviation 1.593 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hematocrit | 0.53 Percentage of RBCs to total blood volume | Standard Deviation 1.28 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hematocrit | 0.05 Percentage of RBCs to total blood volume | Standard Deviation 1.294 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hematocrit | 1.50 Percentage of RBCs to total blood volume | Standard Deviation 1.745 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Hematocrit | 2.07 Percentage of RBCs to total blood volume | Standard Deviation 3.841 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hematocrit | 0.90 Percentage of RBCs to total blood volume | Standard Deviation 0.876 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hematocrit | -0.34 Percentage of RBCs to total blood volume | Standard Deviation 3.14 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hematocrit | -1.28 Percentage of RBCs to total blood volume | Standard Deviation 3.342 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hematocrit | -0.78 Percentage of RBCs to total blood volume | Standard Deviation 2.92 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hematocrit | -1.20 Percentage of RBCs to total blood volume | Standard Deviation 3.251 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hematocrit | 40.78 Percentage of RBCs to total blood volume | Standard Deviation 2.927 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Hematocrit | 0.23 Percentage of RBCs to total blood volume | Standard Deviation 2.007 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hematocrit | 1.15 Percentage of RBCs to total blood volume | Standard Deviation 2.393 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hematocrit | 1.25 Percentage of RBCs to total blood volume | Standard Deviation 1.714 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hematocrit | -1.35 Percentage of RBCs to total blood volume | Standard Deviation 2.914 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hematocrit | -1.26 Percentage of RBCs to total blood volume | Standard Deviation 0.73 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hematocrit | -2.18 Percentage of RBCs to total blood volume | Standard Deviation 1.847 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hematocrit | -1.85 Percentage of RBCs to total blood volume | Standard Deviation 1.771 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hematocrit | 0.22 Percentage of RBCs to total blood volume | Standard Deviation 2.845 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hematocrit | -1.73 Percentage of RBCs to total blood volume | Standard Deviation 1.866 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hematocrit | -1.30 Percentage of RBCs to total blood volume | Standard Deviation 1.687 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hematocrit | 40.87 Percentage of RBCs to total blood volume | Standard Deviation 5.369 |
| Placebo | Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Hematocrit | -1.10 Percentage of RBCs to total blood volume | Standard Deviation 5.412 |
Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Monocytes (abs) | 0.522 10^3 cells/microliter | Standard Deviation 0.1622 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Eosinophils (abs) | -0.008 10^3 cells/microliter | Standard Deviation 0.0685 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Eosinophils (abs) | -0.007 10^3 cells/microliter | Standard Deviation 0.0547 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: WBC | -0.08 10^3 cells/microliter | Standard Deviation 1.28 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Platelets | 13.5 10^3 cells/microliter | Standard Deviation 21.19 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Eosinophils (abs) | -0.002 10^3 cells/microliter | Standard Deviation 0.0898 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Eosinophils (abs) | 0.012 10^3 cells/microliter | Standard Deviation 0.0638 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: WBC | 0.35 10^3 cells/microliter | Standard Deviation 1.693 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Monocytes (abs) | -0.023 10^3 cells/microliter | Standard Deviation 0.1649 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Eosinophils (abs) | 0.212 10^3 cells/microliter | Standard Deviation 0.1298 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Neutrophils(abs) | 0.413 10^3 cells/microliter | Standard Deviation 1.3356 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Lymphocytes(abs) | -0.025 10^3 cells/microliter | Standard Deviation 0.3961 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Neutrophils (abs) | 0.137 10^3 cells/microliter | Standard Deviation 0.9677 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Neutrophils (abs) | -0.348 10^3 cells/microliter | Standard Deviation 1.1549 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Neutrophils (abs) | 3.508 10^3 cells/microliter | Standard Deviation 1.4359 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Lymphocytes (abs) | -0.173 10^3 cells/microliter | Standard Deviation 0.2486 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Neutrophils (abs) | 0.043 10^3 cells/microliter | Standard Deviation 0.8887 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Neutrophils (abs) | 0.405 10^3 cells/microliter | Standard Deviation 1.3205 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Neutrophils (abs) | 0.154 10^3 cells/microliter | Standard Deviation 0.8442 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Platelets | 5.2 10^3 cells/microliter | Standard Deviation 20.97 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Neutrophils (abs) | 0.237 10^3 cells/microliter | Standard Deviation 1.1972 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Monocytes (abs) | -0.020 10^3 cells/microliter | Standard Deviation 0.1753 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Lymphocytes (abs) | 0.012 10^3 cells/microliter | Standard Deviation 0.2175 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Lymphocytes (abs) | 0.023 10^3 cells/microliter | Standard Deviation 0.2299 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Platelets | 4.5 10^3 cells/microliter | Standard Deviation 26.16 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Monocytes (abs) | 0.000 10^3 cells/microliter | Standard Deviation 0.0701 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Lymphocytes (abs) | -0.063 10^3 cells/microliter | Standard Deviation 0.1973 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Platelets | 187.5 10^3 cells/microliter | Standard Deviation 50.91 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Platelets | 5.4 10^3 cells/microliter | Standard Deviation 9.56 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Platelets | -1.0 10^3 cells/microliter | Standard Deviation 15.38 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Lymphocytes (abs) | -0.042 10^3 cells/microliter | Standard Deviation 0.1594 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Lymphocytes (abs) | -0.160 10^3 cells/microliter | Standard Deviation 0.2853 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Monocytes (abs) | -0.005 10^3 cells/microliter | Standard Deviation 0.1566 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Lymphocytes (abs) | 1.470 10^3 cells/microliter | Standard Deviation 0.3329 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Basophils (abs) | -0.008 10^3 cells/microliter | Standard Deviation 0.0147 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: WBC | 5.75 10^3 cells/microliter | Standard Deviation 1.744 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Monocytes (abs) | -0.040 10^3 cells/microliter | Standard Deviation 0.1185 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Basophils (abs) | 0.005 10^3 cells/microliter | Standard Deviation 0.0266 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Basophils (abs) | 0.003 10^3 cells/microliter | Standard Deviation 0.0137 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: WBC | -0.02 10^3 cells/microliter | Standard Deviation 1.163 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Monocytes (abs) | -0.043 10^3 cells/microliter | Standard Deviation 0.1229 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Basophils (abs) | 0.003 10^3 cells/microliter | Standard Deviation 0.0103 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Basophils (abs) | 0.007 10^3 cells/microliter | Standard Deviation 0.0175 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: WBC | 0.15 10^3 cells/microliter | Standard Deviation 1.104 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Platelets | -0.6 10^3 cells/microliter | Standard Deviation 14.17 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Basophils (abs) | 0.003 10^3 cells/microliter | Standard Deviation 0.0137 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Basophils (abs) | 0.014 10^3 cells/microliter | Standard Deviation 0.0358 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: WBC | 0.30 10^3 cells/microliter | Standard Deviation 1.41 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Platelets | 1.2 10^3 cells/microliter | Standard Deviation 13.55 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Basophils (abs) | 0.032 10^3 cells/microliter | Standard Deviation 0.0133 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Eosinophils(abs) | -0.015 10^3 cells/microliter | Standard Deviation 0.074 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: WBC | 0.05 10^3 cells/microliter | Standard Deviation 1.048 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Monocytes (abs) | -0.034 10^3 cells/microliter | Standard Deviation 0.1826 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Eosinophils (abs) | -0.042 10^3 cells/microliter | Standard Deviation 0.0786 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Eosinophils (abs) | 0.028 10^3 cells/microliter | Standard Deviation 0.0567 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: WBC | -0.33 10^3 cells/microliter | Standard Deviation 1.414 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Lymphocytes (abs) | -0.190 10^3 cells/microliter | Standard Deviation 0.2155 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Platelets | 209.3 10^3 cells/microliter | Standard Deviation 39.52 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Platelets | -10.7 10^3 cells/microliter | Standard Deviation 21.99 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Platelets | -14.4 10^3 cells/microliter | Standard Deviation 24.27 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Platelets | 4.0 10^3 cells/microliter | Standard Deviation 22.9 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Platelets | -3.5 10^3 cells/microliter | Standard Deviation 31.05 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Platelets | -12.2 10^3 cells/microliter | Standard Deviation 16.8 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Platelets | -1.2 10^3 cells/microliter | Standard Deviation 28.49 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Platelets | -5.5 10^3 cells/microliter | Standard Deviation 27.29 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Platelets | -11.8 10^3 cells/microliter | Standard Deviation 30.33 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: WBC | 6.08 10^3 cells/microliter | Standard Deviation 1.023 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: WBC | -0.40 10^3 cells/microliter | Standard Deviation 0.839 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: WBC | -0.42 10^3 cells/microliter | Standard Deviation 0.676 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: WBC | -0.28 10^3 cells/microliter | Standard Deviation 1.326 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: WBC | 0.32 10^3 cells/microliter | Standard Deviation 1.341 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: WBC | 0.03 10^3 cells/microliter | Standard Deviation 1.166 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: WBC | -0.13 10^3 cells/microliter | Standard Deviation 1.657 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: WBC | -0.42 10^3 cells/microliter | Standard Deviation 0.882 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: WBC | -0.18 10^3 cells/microliter | Standard Deviation 1.743 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Neutrophils (abs) | 3.813 10^3 cells/microliter | Standard Deviation 1.1002 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Neutrophils (abs) | -0.320 10^3 cells/microliter | Standard Deviation 0.7102 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Neutrophils (abs) | -0.226 10^3 cells/microliter | Standard Deviation 0.7418 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Neutrophils (abs) | -0.062 10^3 cells/microliter | Standard Deviation 0.9878 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Neutrophils (abs) | 0.455 10^3 cells/microliter | Standard Deviation 1.2804 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Neutrophils (abs) | 0.260 10^3 cells/microliter | Standard Deviation 1.1844 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Neutrophils (abs) | 0.092 10^3 cells/microliter | Standard Deviation 1.5919 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Neutrophils(abs) | -0.188 10^3 cells/microliter | Standard Deviation 0.7241 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Neutrophils(abs) | -0.035 10^3 cells/microliter | Standard Deviation 1.3786 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Eosinophils (abs) | 0.242 10^3 cells/microliter | Standard Deviation 0.0823 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Eosinophils (abs) | 0.020 10^3 cells/microliter | Standard Deviation 0.0994 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Eosinophils (abs) | 0.012 10^3 cells/microliter | Standard Deviation 0.1215 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Eosinophils (abs) | 0.074 10^3 cells/microliter | Standard Deviation 0.0832 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Eosinophils (abs) | 0.053 10^3 cells/microliter | Standard Deviation 0.1285 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Eosinophils (abs) | -0.005 10^3 cells/microliter | Standard Deviation 0.0892 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Eosinophils (abs) | 0.012 10^3 cells/microliter | Standard Deviation 0.0467 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Eosinophils(abs) | 0.002 10^3 cells/microliter | Standard Deviation 0.083 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Eosinophils(abs) | -0.010 10^3 cells/microliter | Standard Deviation 0.1122 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Basophils (abs) | 0.048 10^3 cells/microliter | Standard Deviation 0.0371 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Basophils (abs) | -0.012 10^3 cells/microliter | Standard Deviation 0.0549 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Basophils (abs) | -0.016 10^3 cells/microliter | Standard Deviation 0.0611 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Basophils (abs) | -0.014 10^3 cells/microliter | Standard Deviation 0.0404 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Basophils (abs) | -0.022 10^3 cells/microliter | Standard Deviation 0.0422 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Basophils (abs) | -0.027 10^3 cells/microliter | Standard Deviation 0.0344 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Basophils (abs) | -0.025 10^3 cells/microliter | Standard Deviation 0.0378 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Basophils (abs) | -0.027 10^3 cells/microliter | Standard Deviation 0.0294 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Basophils (abs) | -0.028 10^3 cells/microliter | Standard Deviation 0.0223 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Lymphocytes (abs) | 1.528 10^3 cells/microliter | Standard Deviation 0.3669 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Lymphocytes (abs) | -0.088 10^3 cells/microliter | Standard Deviation 0.2491 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Lymphocytes (abs) | -0.256 10^3 cells/microliter | Standard Deviation 0.4282 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Lymphocytes (abs) | -0.145 10^3 cells/microliter | Standard Deviation 0.3142 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Lymphocytes (abs) | -0.188 10^3 cells/microliter | Standard Deviation 0.2584 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Lymphocytes (abs) | -0.192 10^3 cells/microliter | Standard Deviation 0.1985 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Lymphocytes(abs) | -0.200 10^3 cells/microliter | Standard Deviation 0.1579 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Lymphocytes(abs) | -0.128 10^3 cells/microliter | Standard Deviation 0.2971 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Monocytes (abs) | 0.455 10^3 cells/microliter | Standard Deviation 0.144 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Monocytes (abs) | -0.033 10^3 cells/microliter | Standard Deviation 0.0898 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Monocytes (abs) | -0.020 10^3 cells/microliter | Standard Deviation 0.0265 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Monocytes (abs) | -0.022 10^3 cells/microliter | Standard Deviation 0.0991 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Monocytes (abs) | -0.017 10^3 cells/microliter | Standard Deviation 0.1061 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Monocytes (abs) | -0.013 10^3 cells/microliter | Standard Deviation 0.1058 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Monocytes (abs) | -0.017 10^3 cells/microliter | Standard Deviation 0.1216 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Monocytes (abs) | -0.025 10^3 cells/microliter | Standard Deviation 0.1154 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Monocytes (abs) | 0.012 10^3 cells/microliter | Standard Deviation 0.162 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Eosinophils (abs) | -0.008 10^3 cells/microliter | Standard Deviation 0.0643 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Platelets | 19.3 10^3 cells/microliter | Standard Deviation 30.32 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Basophils (abs) | 0.008 10^3 cells/microliter | Standard Deviation 0.0214 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Lymphocytes (abs) | 0.023 10^3 cells/microliter | Standard Deviation 0.2467 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Eosinophils(abs) | -0.057 10^3 cells/microliter | Standard Deviation 0.0831 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Platelets | 5.2 10^3 cells/microliter | Standard Deviation 13.52 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Platelets | -7.0 10^3 cells/microliter | Standard Deviation 22.3 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Lymphocytes (abs) | -0.090 10^3 cells/microliter | Standard Deviation 0.1452 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: WBC | -0.87 10^3 cells/microliter | Standard Deviation 1.571 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Platelets | 9.3 10^3 cells/microliter | Standard Deviation 14.49 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Basophils (abs) | -0.008 10^3 cells/microliter | Standard Deviation 0.0204 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Lymphocytes (abs) | -0.303 10^3 cells/microliter | Standard Deviation 0.2717 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: WBC | -0.35 10^3 cells/microliter | Standard Deviation 1.417 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Platelets | -2.7 10^3 cells/microliter | Standard Deviation 41.86 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Monocytes (abs) | -0.177 10^3 cells/microliter | Standard Deviation 0.2366 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Lymphocytes (abs) | -0.293 10^3 cells/microliter | Standard Deviation 0.0907 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: WBC | -0.54 10^3 cells/microliter | Standard Deviation 0.783 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Monocytes (abs) | -0.017 10^3 cells/microliter | Standard Deviation 0.1188 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Basophils (abs) | 0.008 10^3 cells/microliter | Standard Deviation 0.0194 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Lymphocytes (abs) | -0.192 10^3 cells/microliter | Standard Deviation 0.2218 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Eosinophils(abs) | -0.010 10^3 cells/microliter | Standard Deviation 0.0447 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Monocytes (abs) | -0.084 10^3 cells/microliter | Standard Deviation 0.0899 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Neutrophils (abs) | -0.264 10^3 cells/microliter | Standard Deviation 0.4348 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Platelets | 27.3 10^3 cells/microliter | Standard Deviation 55.97 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Neutrophils (abs) | -0.007 10^3 cells/microliter | Standard Deviation 0.4337 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Monocytes (abs) | -0.102 10^3 cells/microliter | Standard Deviation 0.07 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Basophils (abs) | -0.003 10^3 cells/microliter | Standard Deviation 0.0225 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: WBC | -0.33 10^3 cells/microliter | Standard Deviation 0.463 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Neutrophils (abs) | -0.100 10^3 cells/microliter | Standard Deviation 0.3685 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: WBC | 6.17 10^3 cells/microliter | Standard Deviation 1.334 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Neutrophils (abs) | 3.637 10^3 cells/microliter | Standard Deviation 0.843 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Lymphocytes(abs) | -0.048 10^3 cells/microliter | Standard Deviation 0.2303 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Neutrophils (abs) | 0.218 10^3 cells/microliter | Standard Deviation 1.3491 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Platelets | 198.7 10^3 cells/microliter | Standard Deviation 57.3 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Basophils (abs) | -0.007 10^3 cells/microliter | Standard Deviation 0.0225 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Basophils (abs) | 0.032 10^3 cells/microliter | Standard Deviation 0.0214 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Neutrophils (abs) | -0.313 10^3 cells/microliter | Standard Deviation 1.3322 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Eosinophils (abs) | -0.082 10^3 cells/microliter | Standard Deviation 0.0891 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: WBC | 0.60 10^3 cells/microliter | Standard Deviation 2.199 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Platelets | -1.0 10^3 cells/microliter | Standard Deviation 11.54 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Neutrophils (abs) | -0.398 10^3 cells/microliter | Standard Deviation 0.3572 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Basophils (abs) | 0.007 10^3 cells/microliter | Standard Deviation 0.0378 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Monocytes (abs) | -0.095 10^3 cells/microliter | Standard Deviation 0.0517 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Lymphocytes(abs) | -0.180 10^3 cells/microliter | Standard Deviation 0.36 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Neutrophils(abs) | 0.088 10^3 cells/microliter | Standard Deviation 0.4068 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Monocytes (abs) | -0.077 10^3 cells/microliter | Standard Deviation 0.0789 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Basophils (abs) | -0.012 10^3 cells/microliter | Standard Deviation 0.0256 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Neutrophils(abs) | 0.838 10^3 cells/microliter | Standard Deviation 1.8792 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Basophils (abs) | 0.002 10^3 cells/microliter | Standard Deviation 0.0349 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: WBC | -0.10 10^3 cells/microliter | Standard Deviation 0.395 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Platelets | 15.5 10^3 cells/microliter | Standard Deviation 16.36 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Eosinophils (abs) | 0.208 10^3 cells/microliter | Standard Deviation 0.1338 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Monocytes (abs) | -0.203 10^3 cells/microliter | Standard Deviation 0.1183 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Lymphocytes (abs) | 1.748 10^3 cells/microliter | Standard Deviation 0.4477 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Monocytes (abs) | -0.128 10^3 cells/microliter | Standard Deviation 0.0781 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Eosinophils (abs) | 0.012 10^3 cells/microliter | Standard Deviation 0.0676 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Eosinophils (abs) | -0.045 10^3 cells/microliter | Standard Deviation 0.0547 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: WBC | -0.82 10^3 cells/microliter | Standard Deviation 0.454 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Monocytes (abs) | 0.525 10^3 cells/microliter | Standard Deviation 0.1169 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Eosinophils (abs) | 0.017 10^3 cells/microliter | Standard Deviation 0.0909 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: WBC | -0.07 10^3 cells/microliter | Standard Deviation 0.579 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Eosinophils (abs) | -0.078 10^3 cells/microliter | Standard Deviation 0.0652 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Lymphocytes (abs) | -0.198 10^3 cells/microliter | Standard Deviation 0.1997 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Lymphocytes (abs) | -0.197 10^3 cells/microliter | Standard Deviation 0.376 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Eosinophils (abs) | 0.043 10^3 cells/microliter | Standard Deviation 0.0842 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Eosinophils (abs) | 0.058 10^3 cells/microliter | Standard Deviation 0.1003 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: WBC | -0.76 10^3 cells/microliter | Standard Deviation 1.408 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Monocytes (abs) | -0.080 10^3 cells/microliter | Standard Deviation 0.0718 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Eosinophils (abs) | 0.032 10^3 cells/microliter | Standard Deviation 0.075 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Eosinophils (abs) | 0.030 10^3 cells/microliter | Standard Deviation 0.0903 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: WBC | -1.08 10^3 cells/microliter | Standard Deviation 1.721 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Monocytes (abs) | -0.127 10^3 cells/microliter | Standard Deviation 0.1488 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Eosinophils(abs) | 0.076 10^3 cells/microliter | Standard Deviation 0.1328 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Platelets | -3.2 10^3 cells/microliter | Standard Deviation 18.85 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Eosinophils(abs) | 0.075 10^3 cells/microliter | Standard Deviation 0.1318 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Basophils (abs) | 0.030 10^3 cells/microliter | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: WBC | -1.75 10^3 cells/microliter | Standard Deviation 1.26 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Basophils (abs) | -0.003 10^3 cells/microliter | Standard Deviation 0.0258 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Monocytes (abs) | -0.133 10^3 cells/microliter | Standard Deviation 0.1402 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Basophils (abs) | -0.005 10^3 cells/microliter | Standard Deviation 0.0176 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: WBC | -1.02 10^3 cells/microliter | Standard Deviation 1.88 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Basophils (abs) | 0.000 10^3 cells/microliter | Standard Deviation 0.0216 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Basophils (abs) | 0.002 10^3 cells/microliter | Standard Deviation 0.0217 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: WBC | 7.40 10^3 cells/microliter | Standard Deviation 2.497 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Basophils (abs) | 0.000 10^3 cells/microliter | Standard Deviation 0.0265 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Monocytes (abs) | -0.100 10^3 cells/microliter | Standard Deviation 0.0702 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Basophils (abs) | 0.022 10^3 cells/microliter | Standard Deviation 0.0363 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Platelets | 6.0 10^3 cells/microliter | Standard Deviation 37.05 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Platelets | 0.7 10^3 cells/microliter | Standard Deviation 17.19 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Basophils (abs) | 0.012 10^3 cells/microliter | Standard Deviation 0.0179 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Basophils (abs) | 0.010 10^3 cells/microliter | Standard Deviation 0.0082 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Lymphocytes (abs) | 1.598 10^3 cells/microliter | Standard Deviation 0.381 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Platelets | 0.2 10^3 cells/microliter | Standard Deviation 24.77 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Monocytes (abs) | -0.090 10^3 cells/microliter | Standard Deviation 0.062 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Platelets | -2.0 10^3 cells/microliter | Standard Deviation 35.94 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Lymphocytes (abs) | -0.273 10^3 cells/microliter | Standard Deviation 0.3223 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Lymphocytes (abs) | -0.108 10^3 cells/microliter | Standard Deviation 0.0171 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Platelets | -2.0 10^3 cells/microliter | Standard Deviation 17.72 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Monocytes (abs) | -0.080 10^3 cells/microliter | Standard Deviation 0.1259 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Lymphocytes (abs) | -0.238 10^3 cells/microliter | Standard Deviation 0.3872 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Lymphocytes (abs) | -0.084 10^3 cells/microliter | Standard Deviation 0.4824 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Platelets | 10.4 10^3 cells/microliter | Standard Deviation 29.95 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Monocytes (abs) | -0.068 10^3 cells/microliter | Standard Deviation 0.1283 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Lymphocytes (abs) | -0.152 10^3 cells/microliter | Standard Deviation 0.5413 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Neutrophils (abs) | -0.730 10^3 cells/microliter | Standard Deviation 1.9961 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Neutrophils (abs) | -1.342 10^3 cells/microliter | Standard Deviation 1.2706 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Neutrophils (abs) | 5.077 10^3 cells/microliter | Standard Deviation 2.3807 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Platelets | 204.2 10^3 cells/microliter | Standard Deviation 51.86 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Neutrophils (abs) | -0.925 10^3 cells/microliter | Standard Deviation 1.7647 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Neutrophils (abs) | -0.502 10^3 cells/microliter | Standard Deviation 1.5264 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: WBC | -0.98 10^3 cells/microliter | Standard Deviation 1.513 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Lymphocytes(abs) | 0.118 10^3 cells/microliter | Standard Deviation 0.3841 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Neutrophils (abs) | -0.968 10^3 cells/microliter | Standard Deviation 1.641 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Monocytes (abs) | -0.065 10^3 cells/microliter | Standard Deviation 0.0915 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Neutrophils (abs) | -0.020 10^3 cells/microliter | Standard Deviation 1.9093 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: WBC | -0.82 10^3 cells/microliter | Standard Deviation 1.329 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Neutrophils(abs) | -0.972 10^3 cells/microliter | Standard Deviation 1.1744 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Lymphocytes(abs) | -0.180 10^3 cells/microliter | Standard Deviation 0.1911 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Neutrophils(abs) | -0.815 10^3 cells/microliter | Standard Deviation 1.3199 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Platelets | 9.8 10^3 cells/microliter | Standard Deviation 31.96 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Eosinophils (abs) | 0.162 10^3 cells/microliter | Standard Deviation 0.1005 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: WBC | -0.16 10^3 cells/microliter | Standard Deviation 1.766 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Eosinophils (abs) | 0.027 10^3 cells/microliter | Standard Deviation 0.0871 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Eosinophils (abs) | -0.007 10^3 cells/microliter | Standard Deviation 0.0628 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: WBC | -1.06 10^3 cells/microliter | Standard Deviation 1.324 |
| Placebo | Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Monocytes (abs) | 0.542 10^3 cells/microliter | Standard Deviation 0.1569 |
Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Albumin | -0.12 Gram per deciliter (g/dL) | Standard Deviation 0.313 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Protein | -0.33 Gram per deciliter (g/dL) | Standard Deviation 0.273 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Albumin | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.098 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Albumin | 0.08 Gram per deciliter (g/dL) | Standard Deviation 0.319 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Albumin | -0.10 Gram per deciliter (g/dL) | Standard Deviation 0.19 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Protein | -0.18 Gram per deciliter (g/dL) | Standard Deviation 0.354 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Protein | 7.07 Gram per deciliter (g/dL) | Standard Deviation 0.273 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Albumin | 4.23 Gram per deciliter (g/dL) | Standard Deviation 0.301 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hemoglobin | -0.48 Gram per deciliter (g/dL) | Standard Deviation 0.293 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hemoglobin | -0.18 Gram per deciliter (g/dL) | Standard Deviation 0.627 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Protein | -0.08 Gram per deciliter (g/dL) | Standard Deviation 0.392 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hemoglobin | -0.28 Gram per deciliter (g/dL) | Standard Deviation 0.471 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hemoglobin | -0.03 Gram per deciliter (g/dL) | Standard Deviation 0.622 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Protein | -0.03 Gram per deciliter (g/dL) | Standard Deviation 0.216 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hemoglobin | -0.12 Gram per deciliter (g/dL) | Standard Deviation 0.585 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hemoglobin | -0.36 Gram per deciliter (g/dL) | Standard Deviation 0.493 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hemoglobin | 14.07 Gram per deciliter (g/dL) | Standard Deviation 1.392 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Protein | -0.25 Gram per deciliter (g/dL) | Standard Deviation 0.339 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hemoglobin | -0.42 Gram per deciliter (g/dL) | Standard Deviation 0.462 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Albumin | 0.03 Gram per deciliter (g/dL) | Standard Deviation 0.175 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Albumin | -0.17 Gram per deciliter (g/dL) | Standard Deviation 0.175 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Protein | -0.28 Gram per deciliter (g/dL) | Standard Deviation 0.271 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Protein | -0.25 Gram per deciliter (g/dL) | Standard Deviation 0.274 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Albumin | -0.08 Gram per deciliter (g/dL) | Standard Deviation 0.133 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Protein | -0.13 Gram per deciliter (g/dL) | Standard Deviation 0.25 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Protein | 6.93 Gram per deciliter (g/dL) | Standard Deviation 0.273 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Protein | -0.25 Gram per deciliter (g/dL) | Standard Deviation 0.302 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Protein | -0.25 Gram per deciliter (g/dL) | Standard Deviation 0.207 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Protein | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.293 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Protein | -0.02 Gram per deciliter (g/dL) | Standard Deviation 0.343 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Protein | -0.17 Gram per deciliter (g/dL) | Standard Deviation 0.225 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Protein | -0.17 Gram per deciliter (g/dL) | Standard Deviation 0.383 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Protein | -0.03 Gram per deciliter (g/dL) | Standard Deviation 0.339 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Albumin | 4.48 Gram per deciliter (g/dL) | Standard Deviation 0.194 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Albumin | -0.12 Gram per deciliter (g/dL) | Standard Deviation 0.256 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Albumin | -0.13 Gram per deciliter (g/dL) | Standard Deviation 0.151 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Albumin | -0.02 Gram per deciliter (g/dL) | Standard Deviation 0.286 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Albumin | -0.07 Gram per deciliter (g/dL) | Standard Deviation 0.197 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Albumin | -0.15 Gram per deciliter (g/dL) | Standard Deviation 0.152 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Albumin | -0.10 Gram per deciliter (g/dL) | Standard Deviation 0.155 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Albumin | -0.05 Gram per deciliter (g/dL) | Standard Deviation 0.362 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Albumin | -0.08 Gram per deciliter (g/dL) | Standard Deviation 0.264 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hemoglobin | 14.28 Gram per deciliter (g/dL) | Standard Deviation 0.662 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hemoglobin | -0.38 Gram per deciliter (g/dL) | Standard Deviation 0.337 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hemoglobin | -0.68 Gram per deciliter (g/dL) | Standard Deviation 0.356 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hemoglobin | 0.08 Gram per deciliter (g/dL) | Standard Deviation 0.576 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hemoglobin | -0.12 Gram per deciliter (g/dL) | Standard Deviation 0.714 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hemoglobin | -0.10 Gram per deciliter (g/dL) | Standard Deviation 0.352 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hemoglobin | -0.25 Gram per deciliter (g/dL) | Standard Deviation 0.451 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hemoglobin | 0.00 Gram per deciliter (g/dL) | Standard Deviation 0.525 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Hemoglobin | 0.28 Gram per deciliter (g/dL) | Standard Deviation 1.1136 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Protein | -0.05 Gram per deciliter (g/dL) | Standard Deviation 0.383 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hemoglobin | 0.15 Gram per deciliter (g/dL) | Standard Deviation 0.709 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Albumin | -0.02 Gram per deciliter (g/dL) | Standard Deviation 0.075 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hemoglobin | 0.17 Gram per deciliter (g/dL) | Standard Deviation 0.308 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Albumin | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.232 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Protein | -0.03 Gram per deciliter (g/dL) | Standard Deviation 0.266 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Protein | 6.97 Gram per deciliter (g/dL) | Standard Deviation 0.234 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hemoglobin | 0.18 Gram per deciliter (g/dL) | Standard Deviation 0.523 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Albumin | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.117 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Albumin | 0.00 Gram per deciliter (g/dL) | Standard Deviation 0.167 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Protein | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.319 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Protein | -0.23 Gram per deciliter (g/dL) | Standard Deviation 0.386 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Protein | 0.03 Gram per deciliter (g/dL) | Standard Deviation 0.258 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hemoglobin | -0.25 Gram per deciliter (g/dL) | Standard Deviation 0.991 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Albumin | 4.43 Gram per deciliter (g/dL) | Standard Deviation 0.121 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Albumin | -0.08 Gram per deciliter (g/dL) | Standard Deviation 0.16 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hemoglobin | 13.93 Gram per deciliter (g/dL) | Standard Deviation 1.007 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Protein | -0.05 Gram per deciliter (g/dL) | Standard Deviation 0.259 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Albumin | -0.13 Gram per deciliter (g/dL) | Standard Deviation 0.31 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Protein | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.407 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Protein | -0.23 Gram per deciliter (g/dL) | Standard Deviation 0.207 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hemoglobin | -0.33 Gram per deciliter (g/dL) | Standard Deviation 0.905 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Albumin | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.147 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hemoglobin | -0.55 Gram per deciliter (g/dL) | Standard Deviation 0.819 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Hemoglobin | 0.05 Gram per deciliter (g/dL) | Standard Deviation 0.565 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hemoglobin | -0.44 Gram per deciliter (g/dL) | Standard Deviation 1.029 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Albumin | 0.02 Gram per deciliter (g/dL) | Standard Deviation 0.183 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Hemoglobin | -0.57 Gram per deciliter (g/dL) | Standard Deviation 0.468 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Protein | -0.36 Gram per deciliter (g/dL) | Standard Deviation 0.305 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Albumin | -0.08 Gram per deciliter (g/dL) | Standard Deviation 0.277 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Albumin | -0.14 Gram per deciliter (g/dL) | Standard Deviation 0.321 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Protein | -0.06 Gram per deciliter (g/dL) | Standard Deviation 0.378 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Albumin | 0.00 Gram per deciliter (g/dL) | Standard Deviation 0.354 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Hemoglobin | -0.66 Gram per deciliter (g/dL) | Standard Deviation 0.581 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Albumin | 0.12 Gram per deciliter (g/dL) | Standard Deviation 0.256 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Protein | 6.77 Gram per deciliter (g/dL) | Standard Deviation 0.225 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Albumin | 0.13 Gram per deciliter (g/dL) | Standard Deviation 0.377 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Protein | -0.06 Gram per deciliter (g/dL) | Standard Deviation 0.207 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Hemoglobin | -0.12 Gram per deciliter (g/dL) | Standard Deviation 0.769 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Hemoglobin | 13.80 Gram per deciliter (g/dL) | Standard Deviation 1.669 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Albumin | -0.06 Gram per deciliter (g/dL) | Standard Deviation 0.152 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Protein | -0.10 Gram per deciliter (g/dL) | Standard Deviation 0.434 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Hemoglobin | -0.58 Gram per deciliter (g/dL) | Standard Deviation 0.507 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Hemoglobin | -0.58 Gram per deciliter (g/dL) | Standard Deviation 0.96 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Protein | 0.35 Gram per deciliter (g/dL) | Standard Deviation 0.404 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Hemoglobin | -0.75 Gram per deciliter (g/dL) | Standard Deviation 0.387 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Protein | 0.10 Gram per deciliter (g/dL) | Standard Deviation 0.572 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Protein | -0.15 Gram per deciliter (g/dL) | Standard Deviation 0.266 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Albumin | 4.28 Gram per deciliter (g/dL) | Standard Deviation 0.172 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Protein | 0.00 Gram per deciliter (g/dL) | Standard Deviation 0.529 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Hemoglobin | -0.55 Gram per deciliter (g/dL) | Standard Deviation 1.473 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Albumin | -0.03 Gram per deciliter (g/dL) | Standard Deviation 0.175 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Albumin | -0.12 Gram per deciliter (g/dL) | Standard Deviation 0.331 |
| Placebo | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Hemoglobin | -0.80 Gram per deciliter (g/dL) | Standard Deviation 0.592 |
Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Following hematology parameters were analyzed for laboratory examination: Prothrombin Time (PT), Partial Thromboplastin Time.
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT | 0.20 Second | Standard Deviation 1.259 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT | -0.55 Second | Standard Deviation 0.362 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT | 0.10 Second | Standard Deviation 0.758 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT | -0.25 Second | Standard Deviation 0.327 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT | 11.82 Second | Standard Deviation 0.556 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT | 0.47 Second | Standard Deviation 0.7 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT | -0.32 Second | Standard Deviation 1.326 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT | -0.67 Second | Standard Deviation 0.931 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PTT | 31.12 Second | Standard Deviation 3.842 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PTT | -1.77 Second | Standard Deviation 4.431 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PTT | -4.64 Second | Standard Deviation 7.314 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PTT | -3.08 Second | Standard Deviation 4.275 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PTT | -0.18 Second | Standard Deviation 6.184 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PTT | 0.18 Second | Standard Deviation 5.651 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PTT | -1.83 Second | Standard Deviation 4.898 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PTT | -2.47 Second | Standard Deviation 3.686 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT | 11.53 Second | Standard Deviation 0.505 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PTT | -2.42 Second | Standard Deviation 2.87 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PTT | 32.57 Second | Standard Deviation 4.457 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT | -0.28 Second | Standard Deviation 0.92 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PTT | 0.44 Second | Standard Deviation 2.235 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PTT | 0.45 Second | Standard Deviation 2.338 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PTT | -0.33 Second | Standard Deviation 1.49 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PTT | -0.48 Second | Standard Deviation 3.284 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PTT | 0.90 Second | Standard Deviation 4.901 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT | -0.37 Second | Standard Deviation 0.871 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT | -0.43 Second | Standard Deviation 0.308 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PTT | -2.02 Second | Standard Deviation 1.105 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT | -0.02 Second | Standard Deviation 0.248 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT | -0.42 Second | Standard Deviation 0.407 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT | 0.17 Second | Standard Deviation 0.802 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PTT | 1.92 Second | Standard Deviation 3.381 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PT | -0.05 Second | Standard Deviation 0.75 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT | -0.12 Second | Standard Deviation 0.676 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PTT | 2.78 Second | Standard Deviation 8.713 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT | 0.60 Second | Standard Deviation 1.356 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PTT | 4.83 Second | Standard Deviation 5.654 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT | 0.24 Second | Standard Deviation 0.82 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT | 0.15 Second | Standard Deviation 0.609 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT | -0.28 Second | Standard Deviation 0.783 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PT | -0.73 Second | Standard Deviation 0.528 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PTT | 31.63 Second | Standard Deviation 6.808 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PTT | -3.86 Second | Standard Deviation 5.106 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PTT | -1.00 Second | Standard Deviation 7.216 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PTT | 1.68 Second | Standard Deviation 6.563 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PTT | 1.73 Second | Standard Deviation 12.794 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PTT | 1.06 Second | Standard Deviation 5.949 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT | 11.10 Second | Standard Deviation 1.056 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT | 0.18 Second | Standard Deviation 0.896 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT | 0.12 Second | Standard Deviation 0.766 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PTT | 0.22 Second | Standard Deviation 6.524 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT | 0.37 Second | Standard Deviation 1.221 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PTT | -0.52 Second | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT | -1.00 Second | Standard Deviation 1.383 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PTT | -0.02 Second | Standard Deviation 1.424 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PT | -0.42 Second | Standard Deviation 2.05 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT | -0.27 Second | Standard Deviation 2.025 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT | 11.90 Second | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT | -0.77 Second | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PTT | -2.02 Second | Standard Deviation 2.751 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT | -0.95 Second | Standard Deviation 1.353 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PTT | 0.17 Second | Standard Deviation 2.521 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PTT | 3.95 Second | Standard Deviation 8.973 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT | -0.58 Second | Standard Deviation 1.143 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PTT | -0.52 Second | Standard Deviation 3.801 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT | -0.80 Second | Standard Deviation 1.037 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PTT | 31.23 Second | Standard Deviation 5.46 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT | -0.26 Second | Standard Deviation 2.019 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PTT | 0.00 Second | Standard Deviation 2.302 |
| Placebo | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PTT | -0.28 Second | Standard Deviation 2.869 |
Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: RBC | -0.07 10^6 cells/microliter | Standard Deviation 0.207 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: RBC | -0.10 10^6 cells/microliter | Standard Deviation 0.141 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RBC | -0.02 10^6 cells/microliter | Standard Deviation 0.16 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RBC | -0.12 10^6 cells/microliter | Standard Deviation 0.172 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: RBC | 0.03 10^6 cells/microliter | Standard Deviation 0.207 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: RBC | 0.02 10^6 cells/microliter | Standard Deviation 0.16 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RBC | 4.45 10^6 cells/microliter | Standard Deviation 0.394 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: RBC | -0.03 10^6 cells/microliter | Standard Deviation 0.151 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RBC | 0.10 10^6 cells/microliter | Standard Deviation 0.11 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: RBC | 0.00 10^6 cells/microliter | Standard Deviation 0.255 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: RBC | -0.05 10^6 cells/microliter | Standard Deviation 0.302 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: RBC | -0.03 10^6 cells/microliter | Standard Deviation 0.207 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RBC | -0.03 10^6 cells/microliter | Standard Deviation 0.163 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: RBC | 0.15 10^6 cells/microliter | Standard Deviation 0.442 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RBC | 4.48 10^6 cells/microliter | Standard Deviation 0.407 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: RBC | -0.07 10^6 cells/microliter | Standard Deviation 0.103 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: RBC | -0.18 10^6 cells/microliter | Standard Deviation 0.11 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: RBC | -0.02 10^6 cells/microliter | Standard Deviation 0.214 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RBC | 0.03 10^6 cells/microliter | Standard Deviation 0.32 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: RBC | 0.02 10^6 cells/microliter | Standard Deviation 0.098 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: RBC | -0.14 10^6 cells/microliter | Standard Deviation 0.358 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: RBC | -0.13 10^6 cells/microliter | Standard Deviation 0.242 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: RBC | 0.07 10^6 cells/microliter | Standard Deviation 0.121 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RBC | -0.22 10^6 cells/microliter | Standard Deviation 0.319 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RBC | 4.42 10^6 cells/microliter | Standard Deviation 0.417 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: RBC | -0.13 10^6 cells/microliter | Standard Deviation 0.333 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: RBC | 4.43 10^6 cells/microliter | Standard Deviation 0.677 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: RBC | 0.00 10^6 cells/microliter | Standard Deviation 0.292 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: RBC | -0.23 10^6 cells/microliter | Standard Deviation 0.443 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: RBC | -0.10 10^6 cells/microliter | Standard Deviation 0.335 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: RBC | -0.22 10^6 cells/microliter | Standard Deviation 0.277 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: RBC | -0.23 10^6 cells/microliter | Standard Deviation 0.126 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: RBC | -0.08 10^6 cells/microliter | Standard Deviation 0.277 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: RBC | -0.15 10^6 cells/microliter | Standard Deviation 0.176 |
| Placebo | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: RBC | -0.10 10^6 cells/microliter | Standard Deviation 0.187 |
Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Potassium | -0.20 Milliequivalent per liter (mEq/L) | Standard Deviation 0.276 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bicarbonate | -0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 2.07 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Chloride | -1.3 Milliequivalent per liter (mEq/L) | Standard Deviation 3.72 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Chloride | -1.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.88 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Magnesium | 0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.075 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bicarbonate | 0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 2.94 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Chloride | -0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 3.83 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Sodium | -1.3 Milliequivalent per liter (mEq/L) | Standard Deviation 4.08 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Chloride | -0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 2.94 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bicarbonate | 1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.53 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bicarbonate | 27.0 Milliequivalent per liter (mEq/L) | Standard Deviation 1.55 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bicarbonate | 0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.34 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bicarbonate | 0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.17 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Sodium | 0.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.4 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bicarbonate | 1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 1.76 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Magnesium | -0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.098 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Magnesium | 0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.075 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Sodium | -0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 2.8 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Potassium | 4.52 Milliequivalent per liter (mEq/L) | Standard Deviation 0.204 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Magnesium | 0.00 Milliequivalent per liter (mEq/L) | Standard Deviation 0.089 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Potassium | -0.18 Milliequivalent per liter (mEq/L) | Standard Deviation 0.183 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Sodium | 140.0 Milliequivalent per liter (mEq/L) | Standard Deviation 1.26 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Potassium | -0.18 Milliequivalent per liter (mEq/L) | Standard Deviation 0.223 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Magnesium | -0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.082 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Potassium | -0.28 Milliequivalent per liter (mEq/L) | Standard Deviation 0.248 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Sodium | -0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 3.01 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Potassium | -0.10 Milliequivalent per liter (mEq/L) | Standard Deviation 0.322 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Magnesium | 0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.052 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Potassium | -0.20 Milliequivalent per liter (mEq/L) | Standard Deviation 0.253 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Potassium | 0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.121 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Magnesium | -0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.098 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Magnesium | 1.72 Milliequivalent per liter (mEq/L) | Standard Deviation 0.075 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Sodium | -0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 3.2 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Chloride | 103.8 Milliequivalent per liter (mEq/L) | Standard Deviation 2.48 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Sodium | -2.3 Milliequivalent per liter (mEq/L) | Standard Deviation 3.27 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bicarbonate | 0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.16 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Chloride | -1.8 Milliequivalent per liter (mEq/L) | Standard Deviation 2.79 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Chloride | -0.8 Milliequivalent per liter (mEq/L) | Standard Deviation 2.4 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Sodium | 0.0 Milliequivalent per liter (mEq/L) | Standard Deviation 1.67 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Chloride | -1.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.48 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Potassium | 0.15 Milliequivalent per liter (mEq/L) | Standard Deviation 0.394 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Potassium | -0.07 Milliequivalent per liter (mEq/L) | Standard Deviation 0.266 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Magnesium | -0.05 Milliequivalent per liter (mEq/L) | Standard Deviation 0.176 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Magnesium | -0.05 Milliequivalent per liter (mEq/L) | Standard Deviation 0.138 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Bicarbonate | 0.2 Milliequivalent per liter (mEq/L) | Standard Deviation 3.06 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Potassium | -0.07 Milliequivalent per liter (mEq/L) | Standard Deviation 0.266 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Magnesium | 0.00 Milliequivalent per liter (mEq/L) | Standard Deviation 0.2 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Potassium | 0.40 Milliequivalent per liter (mEq/L) | Standard Deviation 0.369 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Chloride | 0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.25 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Sodium | -0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 4.46 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bicarbonate | -0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 1.21 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Sodium | 1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 3.41 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Chloride | -0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 1.37 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Potassium | 0.08 Milliequivalent per liter (mEq/L) | Standard Deviation 0.248 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bicarbonate | -1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.19 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Magnesium | -0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.103 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Chloride | 1.7 Milliequivalent per liter (mEq/L) | Standard Deviation 3.5 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Magnesium | 0.00 Milliequivalent per liter (mEq/L) | Standard Deviation 0.126 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bicarbonate | -1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 0.84 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Potassium | 0.10 Milliequivalent per liter (mEq/L) | Standard Deviation 0.303 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Chloride | 1.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.34 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Sodium | 0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 4.14 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Sodium | 1.3 Milliequivalent per liter (mEq/L) | Standard Deviation 3.01 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Chloride | 1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 1.79 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Sodium | 137.8 Milliequivalent per liter (mEq/L) | Standard Deviation 5.88 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bicarbonate | -0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 1.87 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Chloride | 100.8 Milliequivalent per liter (mEq/L) | Standard Deviation 4.88 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bicarbonate | 27.3 Milliequivalent per liter (mEq/L) | Standard Deviation 1.03 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Magnesium | 0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.16 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bicarbonate | -1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.07 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Potassium | 0.08 Milliequivalent per liter (mEq/L) | Standard Deviation 0.16 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bicarbonate | -0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 1.51 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Magnesium | -0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.147 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bicarbonate | -0.8 Milliequivalent per liter (mEq/L) | Standard Deviation 1.47 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Magnesium | 1.88 Milliequivalent per liter (mEq/L) | Standard Deviation 0.16 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Sodium | 1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 3.83 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Chloride | 1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.76 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Potassium | -0.05 Milliequivalent per liter (mEq/L) | Standard Deviation 0.468 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Sodium | 1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 3.15 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Chloride | 0.8 Milliequivalent per liter (mEq/L) | Standard Deviation 2.14 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Magnesium | 0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.151 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Chloride | 0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.66 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Potassium | 4.40 Milliequivalent per liter (mEq/L) | Standard Deviation 0.2 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Sodium | 0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 4.97 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Sodium | 0.0 Milliequivalent per liter (mEq/L) | Standard Deviation 1.41 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bicarbonate | -1.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.04 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Sodium | 140.0 Milliequivalent per liter (mEq/L) | Standard Deviation 1.79 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Sodium | 0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 0.96 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Sodium | 0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.17 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Sodium | 0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 3.33 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Sodium | 0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 3.39 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Sodium | 2.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.45 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Sodium | 3.5 Milliequivalent per liter (mEq/L) | Standard Deviation 1.38 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Sodium | 2.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.07 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Sodium | 2.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.32 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Potassium | 4.22 Milliequivalent per liter (mEq/L) | Standard Deviation 0.475 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Potassium | -0.08 Milliequivalent per liter (mEq/L) | Standard Deviation 0.15 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Potassium | -0.12 Milliequivalent per liter (mEq/L) | Standard Deviation 0.504 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Potassium | 0.10 Milliequivalent per liter (mEq/L) | Standard Deviation 0.438 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Potassium | 0.00 Milliequivalent per liter (mEq/L) | Standard Deviation 0.49 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Potassium | -0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.535 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Potassium | 0.08 Milliequivalent per liter (mEq/L) | Standard Deviation 0.467 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Potassium | 0.20 Milliequivalent per liter (mEq/L) | Standard Deviation 0.329 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Potassium | 0.38 Milliequivalent per liter (mEq/L) | Standard Deviation 0.458 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Chloride | 102.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.66 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Chloride | 1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.71 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Chloride | 0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.17 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Chloride | 2.0 Milliequivalent per liter (mEq/L) | Standard Deviation 3.03 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Chloride | 1.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.73 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Chloride | 0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 1.75 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Chloride | 1.3 Milliequivalent per liter (mEq/L) | Standard Deviation 1.03 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Chloride | 0.3 Milliequivalent per liter (mEq/L) | Standard Deviation 1.86 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Chloride | 0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 3.21 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bicarbonate | 26.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.43 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bicarbonate | -1.8 Milliequivalent per liter (mEq/L) | Standard Deviation 4.15 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bicarbonate | -0.5 Milliequivalent per liter (mEq/L) | Standard Deviation 1.87 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bicarbonate | -1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 3.51 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bicarbonate | -0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 1.97 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bicarbonate | -0.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.42 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bicarbonate | 0.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.23 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Bicarbonate | -1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 1.64 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Magnesium | 1.67 Milliequivalent per liter (mEq/L) | Standard Deviation 0.294 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Magnesium | -0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.126 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Magnesium | -0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.133 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Magnesium | 0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.082 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Magnesium | 0.05 Milliequivalent per liter (mEq/L) | Standard Deviation 0.084 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Magnesium | -0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.082 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Magnesium | -0.05 Milliequivalent per liter (mEq/L) | Standard Deviation 0.055 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Magnesium | -0.03 Milliequivalent per liter (mEq/L) | Standard Deviation 0.103 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Magnesium | 0.00 Milliequivalent per liter (mEq/L) | Standard Deviation 0.089 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Chloride | 0.6 Milliequivalent per liter (mEq/L) | Standard Deviation 2.41 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Chloride | 0.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Chloride | -1.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Bicarbonate | -1.4 Milliequivalent per liter (mEq/L) | Standard Deviation 2.07 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Chloride | 104.8 Milliequivalent per liter (mEq/L) | Standard Deviation 2.48 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Potassium | -0.25 Milliequivalent per liter (mEq/L) | Standard Deviation 0.173 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Magnesium | -0.06 Milliequivalent per liter (mEq/L) | Standard Deviation 0.055 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Bicarbonate | -0.8 Milliequivalent per liter (mEq/L) | Standard Deviation 3.43 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Potassium | -0.13 Milliequivalent per liter (mEq/L) | Standard Deviation 0.484 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Sodium | 1.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.28 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Bicarbonate | -1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.94 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Potassium | -0.04 Milliequivalent per liter (mEq/L) | Standard Deviation 0.586 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Potassium | 0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.536 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Sodium | 0.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.97 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Magnesium | 1.83 Milliequivalent per liter (mEq/L) | Standard Deviation 0.052 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Potassium | 0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.593 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Potassium | -0.16 Milliequivalent per liter (mEq/L) | Standard Deviation 0.439 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Sodium | 141.7 Milliequivalent per liter (mEq/L) | Standard Deviation 2.07 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Magnesium | -0.10 Milliequivalent per liter (mEq/L) | Standard Deviation 0 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Potassium | -0.13 Milliequivalent per liter (mEq/L) | Standard Deviation 0.367 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Potassium | -0.23 Milliequivalent per liter (mEq/L) | Standard Deviation 0.427 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Magnesium | -0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.13 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Magnesium | 0.00 Milliequivalent per liter (mEq/L) | Standard Deviation 0.063 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Potassium | 4.42 Milliequivalent per liter (mEq/L) | Standard Deviation 0.354 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Sodium | 1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.45 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Sodium | -1.8 Milliequivalent per liter (mEq/L) | Standard Deviation 3.43 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Magnesium | 0.00 Milliequivalent per liter (mEq/L) | Standard Deviation 0.122 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Sodium | -0.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.48 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Sodium | 0.6 Milliequivalent per liter (mEq/L) | Standard Deviation 3.05 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Magnesium | -0.10 Milliequivalent per liter (mEq/L) | Standard Deviation 0.183 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Bicarbonate | -1.5 Milliequivalent per liter (mEq/L) | Standard Deviation 2.26 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Magnesium | -0.02 Milliequivalent per liter (mEq/L) | Standard Deviation 0.084 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Bicarbonate | -2.8 Milliequivalent per liter (mEq/L) | Standard Deviation 4.12 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Bicarbonate | 28.0 Milliequivalent per liter (mEq/L) | Standard Deviation 1.67 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Chloride | -0.8 Milliequivalent per liter (mEq/L) | Standard Deviation 2.99 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Sodium | 1.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.55 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Bicarbonate | -2.0 Milliequivalent per liter (mEq/L) | Standard Deviation 2.92 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Chloride | -1.8 Milliequivalent per liter (mEq/L) | Standard Deviation 3.54 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Chloride | -0.6 Milliequivalent per liter (mEq/L) | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Sodium | 1.6 Milliequivalent per liter (mEq/L) | Standard Deviation 3.13 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Bicarbonate | -1.6 Milliequivalent per liter (mEq/L) | Standard Deviation 3.51 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Chloride | -0.2 Milliequivalent per liter (mEq/L) | Standard Deviation 3.11 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Chloride | 0.8 Milliequivalent per liter (mEq/L) | Standard Deviation 2.39 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Magnesium | -0.07 Milliequivalent per liter (mEq/L) | Standard Deviation 0.121 |
| Placebo | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Bicarbonate | -1.2 Milliequivalent per liter (mEq/L) | Standard Deviation 2.17 |
Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Urine pH is a method for evaluating urine acidity measured on a 10-point scale ranging from 0 (most acidic) to 9 (most alkaline). A lower pH means more acidity.
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Urine pH | 0.00 units on a scale | Standard Deviation 0.447 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Urine pH | -0.08 units on a scale | Standard Deviation 0.492 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Urine pH | 0.08 units on a scale | Standard Deviation 0.585 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Urine pH | -0.08 units on a scale | Standard Deviation 0.376 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Urine pH | -0.17 units on a scale | Standard Deviation 0.258 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Urine pH | -0.17 units on a scale | Standard Deviation 0.408 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Urine pH | -0.25 units on a scale | Standard Deviation 0.274 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Urine pH | 6.33 units on a scale | Standard Deviation 0.408 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Urine pH | 0.00 units on a scale | Standard Deviation 0.316 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Urine pH | 5.92 units on a scale | Standard Deviation 0.376 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Urine pH | 0.42 units on a scale | Standard Deviation 0.376 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Urine pH | 0.17 units on a scale | Standard Deviation 0.408 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Urine pH | 0.00 units on a scale | Standard Deviation 0.447 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Urine pH | 0.50 units on a scale | Standard Deviation 0.548 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Urine pH | 0.30 units on a scale | Standard Deviation 0.671 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Urine pH | 0.25 units on a scale | Standard Deviation 0.689 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Urine pH | 0.33 units on a scale | Standard Deviation 0.408 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Urine pH | 0.08 units on a scale | Standard Deviation 0.204 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Urine pH | 0.17 units on a scale | Standard Deviation 0.408 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Urine pH | 0.30 units on a scale | Standard Deviation 0.447 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Urine pH | 0.25 units on a scale | Standard Deviation 0.524 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Urine pH | 0.17 units on a scale | Standard Deviation 0.516 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Urine pH | 6.00 units on a scale | Standard Deviation 0 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Urine pH | 0.25 units on a scale | Standard Deviation 0.418 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Urine pH | 0.75 units on a scale | Standard Deviation 0.935 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Urine pH | 0.25 units on a scale | Standard Deviation 0.524 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: Urine pH | 0.08 units on a scale | Standard Deviation 0.585 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: Urine pH | 0.00 units on a scale | Standard Deviation 0.354 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: Urine pH | -0.20 units on a scale | Standard Deviation 0.57 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: Urine pH | 0.20 units on a scale | Standard Deviation 0.274 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: Urine pH | -0.17 units on a scale | Standard Deviation 0.258 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: Urine pH | -0.08 units on a scale | Standard Deviation 0.492 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: Urine pH | 0.00 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: Urine pH | 6.00 units on a scale | Standard Deviation 0.316 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: Urine pH | -0.13 units on a scale | Standard Deviation 0.479 |
Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Urine specific gravity is a measure of the ratio of the density of urine to the density of water.
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: USG | -0.0010 ratio | Standard Deviation 0.0094 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: USG | -0.0018 ratio | Standard Deviation 0.00741 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: USG | -0.0013 ratio | Standard Deviation 0.00266 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: USG | -0.0010 ratio | Standard Deviation 0.00654 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: USG | 0.0008 ratio | Standard Deviation 0.00884 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: USG | -0.0018 ratio | Standard Deviation 0.0095 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: USG | 1.0197 ratio | Standard Deviation 0.00565 |
| RN6G 5 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: USG | -0.0002 ratio | Standard Deviation 0.00462 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: USG | -0.0020 ratio | Standard Deviation 0.00447 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: USG | 1.0150 ratio | Standard Deviation 0.00529 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: USG | 0.0012 ratio | Standard Deviation 0.00462 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: USG | -0.0003 ratio | Standard Deviation 0.00787 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: USG | -0.0008 ratio | Standard Deviation 0.00376 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: USG | -0.0005 ratio | Standard Deviation 0.00625 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: USG | -0.0012 ratio | Standard Deviation 0.00559 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: USG | -0.0003 ratio | Standard Deviation 0.00497 |
| RN6G 10 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: USG | -0.0028 ratio | Standard Deviation 0.00768 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: USG | 0.0045 ratio | Standard Deviation 0.00568 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: USG | 0.0047 ratio | Standard Deviation 0.0068 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: USG | 1.0138 ratio | Standard Deviation 0.00343 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: USG | 0.0058 ratio | Standard Deviation 0.00591 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: USG | 0.0020 ratio | Standard Deviation 0.00636 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: USG | 0.0022 ratio | Standard Deviation 0.00293 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: USG | 0.0038 ratio | Standard Deviation 0.00366 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: USG | -0.0002 ratio | Standard Deviation 0.00293 |
| RN6G 15 mg/kg | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: USG | 0.0015 ratio | Standard Deviation 0.0065 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: USG | -0.0020 ratio | Standard Deviation 0.00474 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: USG | -0.0022 ratio | Standard Deviation 0.00527 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: USG | 0.0002 ratio | Standard Deviation 0.00277 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: USG | -0.0022 ratio | Standard Deviation 0.00492 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: USG | 1.0242 ratio | Standard Deviation 0.00615 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: USG | -0.0010 ratio | Standard Deviation 0.00566 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: USG | -0.0024 ratio | Standard Deviation 0.00493 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: USG | -0.0025 ratio | Standard Deviation 0.00259 |
| Placebo | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: USG | -0.0043 ratio | Standard Deviation 0.00383 |
Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time frame: Baseline, Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 7687.9 Picogram per milliliter (pg/ml) | Standard Deviation 915.03 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 6047.9 Picogram per milliliter (pg/ml) | Standard Deviation 751.77 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 15889.6 Picogram per milliliter (pg/ml) | Standard Deviation 1923.62 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 10751.3 Picogram per milliliter (pg/ml) | Standard Deviation 796.75 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 6352.9 Picogram per milliliter (pg/ml) | Standard Deviation 513.41 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 4626.3 Picogram per milliliter (pg/ml) | Standard Deviation 506.1 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | 1939.6 Picogram per milliliter (pg/ml) | Standard Deviation 185.16 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 10302.9 Picogram per milliliter (pg/ml) | Standard Deviation 2886.26 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 2809.6 Picogram per milliliter (pg/ml) | Standard Deviation 534.82 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 11557.9 Picogram per milliliter (pg/ml) | Standard Deviation 2152.82 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 13922.9 Picogram per milliliter (pg/ml) | Standard Deviation 2470.45 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 12626.3 Picogram per milliliter (pg/ml) | Standard Deviation 2294.39 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 3159.6 Picogram per milliliter (pg/ml) | Standard Deviation 510.52 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 1271.3 Picogram per milliliter (pg/ml) | Standard Deviation 131.35 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 10402.9 Picogram per milliliter (pg/ml) | Standard Deviation 1699.34 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 160.4 Picogram per milliliter (pg/ml) | Standard Deviation 36.33 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 10071.3 Picogram per milliliter (pg/ml) | Standard Deviation 1097.81 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 3534.6 Picogram per milliliter (pg/ml) | Standard Deviation 1383.04 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 15272.9 Picogram per milliliter (pg/ml) | Standard Deviation 2939.43 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 8517.9 Picogram per milliliter (pg/ml) | Standard Deviation 1608.78 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 12089.6 Picogram per milliliter (pg/ml) | Standard Deviation 2224.22 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 20889.6 Picogram per milliliter (pg/ml) | Standard Deviation 2456.19 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 12239.6 Picogram per milliliter (pg/ml) | Standard Deviation 1315.07 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 26550.3 Picogram per milliliter (pg/ml) | Standard Deviation 5860.63 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 199.7 Picogram per milliliter (pg/ml) | Standard Deviation 24.19 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 1306.4 Picogram per milliliter (pg/ml) | Standard Deviation 184.77 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | 2082.4 Picogram per milliliter (pg/ml) | Standard Deviation 457.09 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 3290.3 Picogram per milliliter (pg/ml) | Standard Deviation 525.32 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 10256.8 Picogram per milliliter (pg/ml) | Standard Deviation 1125.2 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 18817.0 Picogram per milliliter (pg/ml) | Standard Deviation 4600.38 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 16450.3 Picogram per milliliter (pg/ml) | Standard Deviation 4571.75 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 12467.0 Picogram per milliliter (pg/ml) | Standard Deviation 3360.84 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 9117.0 Picogram per milliliter (pg/ml) | Standard Deviation 2492.73 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 18746.0 Picogram per milliliter (pg/ml) | Standard Deviation 4221.27 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 14645.3 Picogram per milliliter (pg/ml) | Standard Deviation 5174.94 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 24750.3 Picogram per milliliter (pg/ml) | Standard Deviation 5951.71 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 20800.3 Picogram per milliliter (pg/ml) | Standard Deviation 6538.53 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 25900.3 Picogram per milliliter (pg/ml) | Standard Deviation 6385.93 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 23517.0 Picogram per milliliter (pg/ml) | Standard Deviation 6359.32 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 20192.0 Picogram per milliliter (pg/ml) | Standard Deviation 10768.73 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 25550.3 Picogram per milliliter (pg/ml) | Standard Deviation 6073.42 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 26717.0 Picogram per milliliter (pg/ml) | Standard Deviation 5581.26 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 25283.7 Picogram per milliliter (pg/ml) | Standard Deviation 5234.95 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 31733.7 Picogram per milliliter (pg/ml) | Standard Deviation 6395.71 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | 25050.3 Picogram per milliliter (pg/ml) | Standard Deviation 5480.9 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 21517.0 Picogram per milliliter (pg/ml) | Standard Deviation 5926.14 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 8518.7 Picogram per milliliter (pg/ml) | Standard Deviation 2946.68 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | 2483.7 Picogram per milliliter (pg/ml) | Standard Deviation 1124.28 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 209.2 Picogram per milliliter (pg/ml) | Standard Deviation 13.26 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 36114.8 Picogram per milliliter (pg/ml) | Standard Deviation 6268.68 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 37614.8 Picogram per milliliter (pg/ml) | Standard Deviation 8703.34 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 29170.8 Picogram per milliliter (pg/ml) | Standard Deviation 5936.75 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | 3340.8 Picogram per milliliter (pg/ml) | Standard Deviation 994.48 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 36750.8 Picogram per milliliter (pg/ml) | Standard Deviation 14910.47 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 3202.3 Picogram per milliliter (pg/ml) | Standard Deviation 730.89 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 1548.8 Picogram per milliliter (pg/ml) | Standard Deviation 398.99 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 14190.8 Picogram per milliliter (pg/ml) | Standard Deviation 3337.13 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 36750.8 Picogram per milliliter (pg/ml) | Standard Deviation 5023.07 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 39990.8 Picogram per milliliter (pg/ml) | Standard Deviation 8261.8 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 15410.8 Picogram per milliliter (pg/ml) | Standard Deviation 3844.36 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 33910.8 Picogram per milliliter (pg/ml) | Standard Deviation 4820.26 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 17990.8 Picogram per milliliter (pg/ml) | Standard Deviation 4568.62 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 28250.8 Picogram per milliliter (pg/ml) | Standard Deviation 2534.65 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 24150.8 Picogram per milliliter (pg/ml) | Standard Deviation 1138.42 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 24150.8 Picogram per milliliter (pg/ml) | Standard Deviation 3178.81 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 11164.8 Picogram per milliliter (pg/ml) | Standard Deviation 563.89 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 34470.8 Picogram per milliliter (pg/ml) | Standard Deviation 7089.1 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 20630.8 Picogram per milliliter (pg/ml) | Standard Deviation 3400.87 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 23270.8 Picogram per milliliter (pg/ml) | Standard Deviation 1691.32 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 19050.8 Picogram per milliliter (pg/ml) | Standard Deviation 3495.78 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | 47310.8 Picogram per milliliter (pg/ml) | Standard Deviation 2244.59 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 26910.8 Picogram per milliliter (pg/ml) | Standard Deviation 1110.6 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | 2264.8 Picogram per milliliter (pg/ml) | Standard Deviation 438.4 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | -33.0 Picogram per milliliter (pg/ml) | Standard Deviation 24.37 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | -35.8 Picogram per milliliter (pg/ml) | Standard Deviation 37.98 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | -15.6 Picogram per milliliter (pg/ml) | Standard Deviation 61.32 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 224.3 Picogram per milliliter (pg/ml) | Standard Deviation 61.26 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | -15.6 Picogram per milliliter (pg/ml) | Standard Deviation 36.92 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | -5.5 Picogram per milliliter (pg/ml) | Standard Deviation 21.94 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | 26.8 Picogram per milliliter (pg/ml) | Standard Deviation 87.01 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | -18.6 Picogram per milliliter (pg/ml) | Standard Deviation 35.53 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 4.2 Picogram per milliliter (pg/ml) | Standard Deviation 27.8 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 7.0 Picogram per milliliter (pg/ml) | Standard Deviation 56.04 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 26.8 Picogram per milliliter (pg/ml) | Standard Deviation 102.19 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | -0.7 Picogram per milliliter (pg/ml) | Standard Deviation 27.1 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | -20.4 Picogram per milliliter (pg/ml) | Standard Deviation 52.83 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | -9.0 Picogram per milliliter (pg/ml) | Standard Deviation 41.35 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | -31.0 Picogram per milliliter (pg/ml) | Standard Deviation 27.6 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | -3.7 Picogram per milliliter (pg/ml) | Standard Deviation 21.1 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | -27.4 Picogram per milliliter (pg/ml) | Standard Deviation 38.63 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 8.2 Picogram per milliliter (pg/ml) | Standard Deviation 27.46 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | -3.0 Picogram per milliliter (pg/ml) | Standard Deviation 17.44 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | -24.2 Picogram per milliliter (pg/ml) | Standard Deviation 40.38 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | -7.7 Picogram per milliliter (pg/ml) | Standard Deviation 46.88 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | -6.5 Picogram per milliliter (pg/ml) | Standard Deviation 13.91 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 15.3 Picogram per milliliter (pg/ml) | Standard Deviation 66.79 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | -16.8 Picogram per milliliter (pg/ml) | Standard Deviation 46.67 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | -2.8 Picogram per milliliter (pg/ml) | Standard Deviation 16.02 |
Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time frame: Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 8.6 picogram per milliliter (pg/ml) | Standard Deviation 9.82 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 39.5 picogram per milliliter (pg/ml) | Standard Deviation 4.78 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 34.0 picogram per milliliter (pg/ml) | Standard Deviation 5.61 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 65.3 picogram per milliliter (pg/ml) | Standard Deviation 15.08 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | 84.6 picogram per milliliter (pg/ml) | Standard Deviation 21.5 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 100.0 picogram per milliliter (pg/ml) | Standard Deviation 18.5 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 88.6 picogram per milliliter (pg/ml) | Standard Deviation 32.58 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 42.1 picogram per milliliter (pg/ml) | Standard Deviation 16.79 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 18.7 picogram per milliliter (pg/ml) | Standard Deviation 9.18 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 13.9 picogram per milliliter (pg/ml) | Standard Deviation 5.23 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 4.8 picogram per milliliter (pg/ml) | Standard Deviation 3.31 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 31.3 picogram per milliliter (pg/ml) | Standard Deviation 7.24 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 18.0 picogram per milliliter (pg/ml) | Standard Deviation 7.94 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 28.9 picogram per milliliter (pg/ml) | Standard Deviation 11.25 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 25.6 picogram per milliliter (pg/ml) | Standard Deviation 3.6 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 41.9 picogram per milliliter (pg/ml) | Standard Deviation 6.37 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 26.2 picogram per milliliter (pg/ml) | Standard Deviation 8.53 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 56.3 picogram per milliliter (pg/ml) | Standard Deviation 11.71 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 37.2 picogram per milliliter (pg/ml) | Standard Deviation 8.51 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 87.8 picogram per milliliter (pg/ml) | Standard Deviation 10.7 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 113.2 picogram per milliliter (pg/ml) | Standard Deviation 19.82 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 132.3 picogram per milliliter (pg/ml) | Standard Deviation 12.73 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 120.0 picogram per milliliter (pg/ml) | Standard Deviation 15.08 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 209.2 picogram per milliliter (pg/ml) | Standard Deviation 51.64 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 80.2 picogram per milliliter (pg/ml) | Standard Deviation 59.94 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 77.4 picogram per milliliter (pg/ml) | Standard Deviation 26.92 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 72.7 picogram per milliliter (pg/ml) | Standard Deviation 50.7 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | -1.8 picogram per milliliter (pg/ml) | Standard Deviation 41.26 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 8.4 picogram per milliliter (pg/ml) | Standard Deviation 28.46 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | -3.6 picogram per milliliter (pg/ml) | Standard Deviation 40.36 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 67.3 picogram per milliliter (pg/ml) | Standard Deviation 36.14 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 177.5 picogram per milliliter (pg/ml) | Standard Deviation 67.55 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 72.4 picogram per milliliter (pg/ml) | Standard Deviation 14.51 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 243.7 picogram per milliliter (pg/ml) | Standard Deviation 58.08 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | 126.8 picogram per milliliter (pg/ml) | Standard Deviation 36.79 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 50.9 picogram per milliliter (pg/ml) | Standard Deviation 31.77 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 179.5 picogram per milliliter (pg/ml) | Standard Deviation 34.06 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 194.8 picogram per milliliter (pg/ml) | Standard Deviation 48.89 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 56.6 picogram per milliliter (pg/ml) | Standard Deviation 61.02 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 42.4 picogram per milliliter (pg/ml) | Standard Deviation 43.12 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 78.0 picogram per milliliter (pg/ml) | Standard Deviation 51.53 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 56.3 picogram per milliliter (pg/ml) | Standard Deviation 54.71 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 280.2 picogram per milliliter (pg/ml) | Standard Deviation 81.8 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 94.4 picogram per milliliter (pg/ml) | Standard Deviation 49.79 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 33.2 picogram per milliliter (pg/ml) | Standard Deviation 34.62 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 88.2 picogram per milliliter (pg/ml) | Standard Deviation 58.68 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 115.0 picogram per milliliter (pg/ml) | Standard Deviation 68.5 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | 113.4 picogram per milliliter (pg/ml) | Standard Deviation 72.67 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 71.2 picogram per milliliter (pg/ml) | Standard Deviation 13.06 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 360.9 picogram per milliliter (pg/ml) | Standard Deviation 66.62 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 136.3 picogram per milliliter (pg/ml) | Standard Deviation 9.43 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 141.1 picogram per milliliter (pg/ml) | Standard Deviation 47.02 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 101.3 picogram per milliliter (pg/ml) | Standard Deviation 25.8 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 292.9 picogram per milliliter (pg/ml) | Standard Deviation 57.03 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 45.6 picogram per milliliter (pg/ml) | Standard Deviation 14.6 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 262.6 picogram per milliliter (pg/ml) | Standard Deviation 113.24 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 404.7 picogram per milliliter (pg/ml) | Standard Deviation 84.86 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | 4.8 picogram per milliliter (pg/ml) | Standard Deviation 5.31 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 68.3 picogram per milliliter (pg/ml) | Standard Deviation 29.29 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | 229.5 picogram per milliliter (pg/ml) | Standard Deviation 29.57 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 144.5 picogram per milliliter (pg/ml) | Standard Deviation 29.38 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 46.9 picogram per milliliter (pg/ml) | Standard Deviation 8.62 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 144.1 picogram per milliliter (pg/ml) | Standard Deviation 35.08 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 75.9 picogram per milliliter (pg/ml) | Standard Deviation 19.03 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 328.4 picogram per milliliter (pg/ml) | Standard Deviation 99.74 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 154.9 picogram per milliliter (pg/ml) | Standard Deviation 49.51 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 180.1 picogram per milliliter (pg/ml) | Standard Deviation 18.23 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 257.7 picogram per milliliter (pg/ml) | Standard Deviation 63.99 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 104.1 picogram per milliliter (pg/ml) | Standard Deviation 21.92 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | 193.9 picogram per milliliter (pg/ml) | Standard Deviation 65.55 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 168.9 picogram per milliliter (pg/ml) | Standard Deviation 34.85 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 123.1 picogram per milliliter (pg/ml) | Standard Deviation 23.36 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 124.9 picogram per milliliter (pg/ml) | Standard Deviation 39.52 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | -26.1 picogram per milliliter (pg/ml) | Standard Deviation 24.22 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H post-dose Day 1 | 4.0 picogram per milliliter (pg/ml) | Standard Deviation 5.75 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | -13.3 picogram per milliliter (pg/ml) | Standard Deviation 26.69 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 3.9 picogram per milliliter (pg/ml) | Standard Deviation 32 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 9.1 picogram per milliliter (pg/ml) | Standard Deviation 22.03 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | -28.7 picogram per milliliter (pg/ml) | Standard Deviation 31.64 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 8.4 picogram per milliliter (pg/ml) | Standard Deviation 22.71 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | -21.9 picogram per milliliter (pg/ml) | Standard Deviation 27.63 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | -4.3 picogram per milliliter (pg/ml) | Standard Deviation 11.73 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | -12.6 picogram per milliliter (pg/ml) | Standard Deviation 25.16 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | -15.9 picogram per milliliter (pg/ml) | Standard Deviation 28.84 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | -10.5 picogram per milliliter (pg/ml) | Standard Deviation 39.49 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | -22.3 picogram per milliliter (pg/ml) | Standard Deviation 27.87 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | -29.3 picogram per milliliter (pg/ml) | Standard Deviation 25.98 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | -14.7 picogram per milliliter (pg/ml) | Standard Deviation 26.98 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | -17.8 picogram per milliliter (pg/ml) | Standard Deviation 28.09 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | -18.8 picogram per milliliter (pg/ml) | Standard Deviation 22.91 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | -19.9 picogram per milliliter (pg/ml) | Standard Deviation 24.25 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | -10.9 picogram per milliliter (pg/ml) | Standard Deviation 43.12 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | -8.5 picogram per milliliter (pg/ml) | Standard Deviation 42.38 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | -35.9 picogram per milliliter (pg/ml) | Standard Deviation 26.66 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 61.4 picogram per milliliter (pg/ml) | Standard Deviation 31.71 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | -7.7 picogram per milliliter (pg/ml) | Standard Deviation 16.71 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H post-dose Day 1 | -4.0 picogram per milliliter (pg/ml) | Standard Deviation 19.86 |
| Placebo | Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | -21.7 picogram per milliliter (pg/ml) | Standard Deviation 25.89 |
Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Amyloid (A) Beta (1-X) is a primary activator of complement in Alzheimer's disease (AD).
Time frame: Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 62226.8 Picogram per milliliter (pg/ml) | Standard Deviation 17554.96 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 371.8 Picogram per milliliter (pg/ml) | Standard Deviation 284.73 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 25303.0 Picogram per milliliter (pg/ml) | Standard Deviation 4293.92 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 29386.3 Picogram per milliliter (pg/ml) | Standard Deviation 3246.3 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 3340.5 Picogram per milliliter (pg/ml) | Standard Deviation 386.71 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 50269.8 Picogram per milliliter (pg/ml) | Standard Deviation 7129.73 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 17782.7 Picogram per milliliter (pg/ml) | Standard Deviation 4264.51 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 46295.7 Picogram per milliliter (pg/ml) | Standard Deviation 7585.69 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 49017.8 Picogram per milliliter (pg/ml) | Standard Deviation 6793.71 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 27212.1 Picogram per milliliter (pg/ml) | Standard Deviation 12018.62 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 8777.5 Picogram per milliliter (pg/ml) | Standard Deviation 1441.65 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 20950.3 Picogram per milliliter (pg/ml) | Standard Deviation 6951.3 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 33804.2 Picogram per milliliter (pg/ml) | Standard Deviation 5420.83 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4H post-dose Day 1 | 7850.0 Picogram per milliliter (pg/ml) | Standard Deviation 1490.33 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 41329.3 Picogram per milliliter (pg/ml) | Standard Deviation 12376.68 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 34071.5 Picogram per milliliter (pg/ml) | Standard Deviation 4062.24 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 52558.0 Picogram per milliliter (pg/ml) | Standard Deviation 6374.13 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 51102.8 Picogram per milliliter (pg/ml) | Standard Deviation 6552.83 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 23723.0 Picogram per milliliter (pg/ml) | Standard Deviation 4080.35 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 50329.3 Picogram per milliliter (pg/ml) | Standard Deviation 9389.75 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2H post-dose Day 1 | 5118.7 Picogram per milliliter (pg/ml) | Standard Deviation 709 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 41991.0 Picogram per milliliter (pg/ml) | Standard Deviation 7209.04 |
| RN6G 5 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 42393.7 Picogram per milliliter (pg/ml) | Standard Deviation 7739.27 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 70846.5 Picogram per milliliter (pg/ml) | Standard Deviation 24378.68 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 102384.7 Picogram per milliliter (pg/ml) | Standard Deviation 17624.73 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 36042.0 Picogram per milliliter (pg/ml) | Standard Deviation 25934.3 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2H post-dose Day 1 | 4821.2 Picogram per milliliter (pg/ml) | Standard Deviation 1114.32 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 89908.2 Picogram per milliliter (pg/ml) | Standard Deviation 28896.82 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 98349.2 Picogram per milliliter (pg/ml) | Standard Deviation 20226.44 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 114474.3 Picogram per milliliter (pg/ml) | Standard Deviation 28268.9 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 124417.0 Picogram per milliliter (pg/ml) | Standard Deviation 26689.05 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4H post-dose Day 1 | 6992.7 Picogram per milliliter (pg/ml) | Standard Deviation 1716.83 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 102548.2 Picogram per milliliter (pg/ml) | Standard Deviation 22902.22 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 1596.8 Picogram per milliliter (pg/ml) | Standard Deviation 2794.08 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 103651.8 Picogram per milliliter (pg/ml) | Standard Deviation 27880.97 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 33566.0 Picogram per milliliter (pg/ml) | Standard Deviation 4698.42 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 88678.7 Picogram per milliliter (pg/ml) | Standard Deviation 22431.39 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | 13550.8 Picogram per milliliter (pg/ml) | Standard Deviation 5901.76 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | 141033.8 Picogram per milliliter (pg/ml) | Standard Deviation 22685.63 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 69611.3 Picogram per milliliter (pg/ml) | Standard Deviation 21077.31 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 121176.2 Picogram per milliliter (pg/ml) | Standard Deviation 34652.27 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 54407.7 Picogram per milliliter (pg/ml) | Standard Deviation 15467.03 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 3205.5 Picogram per milliliter (pg/ml) | Standard Deviation 856.06 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 35848.3 Picogram per milliliter (pg/ml) | Standard Deviation 9540.26 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 107243.5 Picogram per milliliter (pg/ml) | Standard Deviation 28813.61 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 101938.3 Picogram per milliliter (pg/ml) | Standard Deviation 21440.86 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 87735.4 Picogram per milliliter (pg/ml) | Standard Deviation 19304.46 |
| RN6G 10 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 35489.0 Picogram per milliliter (pg/ml) | Standard Deviation 11571.26 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | 190913.6 Picogram per milliliter (pg/ml) | Standard Deviation 29331.01 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 200.0 Picogram per milliliter (pg/ml) | Standard Deviation 0 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 3947.2 Picogram per milliliter (pg/ml) | Standard Deviation 1822.39 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2H post-dose Day 1 | 5610.8 Picogram per milliliter (pg/ml) | Standard Deviation 2544.7 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4H post-dose Day 1 | 7874.3 Picogram per milliliter (pg/ml) | Standard Deviation 2158.56 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | 37862.0 Picogram per milliliter (pg/ml) | Standard Deviation 1069.86 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 94017.0 Picogram per milliliter (pg/ml) | Standard Deviation 7060.55 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | 80138.0 Picogram per milliliter (pg/ml) | Standard Deviation 13795.55 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | 71190.6 Picogram per milliliter (pg/ml) | Standard Deviation 7553.42 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | 57701.0 Picogram per milliliter (pg/ml) | Standard Deviation 14705.1 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | 110278.0 Picogram per milliliter (pg/ml) | Standard Deviation 20296.92 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | 98343.8 Picogram per milliliter (pg/ml) | Standard Deviation 21336.44 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 149272.0 Picogram per milliliter (pg/ml) | Standard Deviation 23898.1 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 120091.6 Picogram per milliliter (pg/ml) | Standard Deviation 5895.1 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 157448.0 Picogram per milliliter (pg/ml) | Standard Deviation 33235.41 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 140917.6 Picogram per milliliter (pg/ml) | Standard Deviation 17498.78 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | 168767.8 Picogram per milliliter (pg/ml) | Standard Deviation 7272.93 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | 154350.0 Picogram per milliliter (pg/ml) | Standard Deviation 9459.75 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | 140246.0 Picogram per milliliter (pg/ml) | Standard Deviation 15770.21 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | 136109.5 Picogram per milliliter (pg/ml) | Standard Deviation 12883.65 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | 153793.0 Picogram per milliliter (pg/ml) | Standard Deviation 15312.09 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | 80464.2 Picogram per milliliter (pg/ml) | Standard Deviation 11546.49 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | 161691.4 Picogram per milliliter (pg/ml) | Standard Deviation 21292.74 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | 57692.0 Picogram per milliliter (pg/ml) | Standard Deviation 16310.16 |
| RN6G 15 mg/kg | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | 12127.2 Picogram per milliliter (pg/ml) | Standard Deviation 3196.16 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 56 | -36.3 Picogram per milliliter (pg/ml) | Standard Deviation 305.27 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1H post-dose Day 1 | 0.3 Picogram per milliliter (pg/ml) | Standard Deviation 83.39 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2 H Post-dose Day 140 | -137.3 Picogram per milliliter (pg/ml) | Standard Deviation 135.93 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 45 | -6.5 Picogram per milliliter (pg/ml) | Standard Deviation 209.72 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 28 | -69.7 Picogram per milliliter (pg/ml) | Standard Deviation 239.14 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at day 304/ET | -164.3 Picogram per milliliter (pg/ml) | Standard Deviation 167.57 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4 H Post-dose Day 140 | -144.2 Picogram per milliliter (pg/ml) | Standard Deviation 158.04 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 19 | -62.5 Picogram per milliliter (pg/ml) | Standard Deviation 106.16 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 14 | -66.2 Picogram per milliliter (pg/ml) | Standard Deviation 103.72 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 224 | -110.3 Picogram per milliliter (pg/ml) | Standard Deviation 138.97 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 141 | -11.0 Picogram per milliliter (pg/ml) | Standard Deviation 30.66 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 7 | 16.8 Picogram per milliliter (pg/ml) | Standard Deviation 52.82 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 103 | 116.6 Picogram per milliliter (pg/ml) | Standard Deviation 296.52 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 154 | -103.5 Picogram per milliliter (pg/ml) | Standard Deviation 85.83 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 2 | -9.8 Picogram per milliliter (pg/ml) | Standard Deviation 132.42 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 4H post-dose Day 1 | 1.7 Picogram per milliliter (pg/ml) | Standard Deviation 225.19 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Baseline | 386.5 Picogram per milliliter (pg/ml) | Standard Deviation 174.33 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 131 | -61.6 Picogram per milliliter (pg/ml) | Standard Deviation 131.01 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 168 | -64.6 Picogram per milliliter (pg/ml) | Standard Deviation 132.4 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at pre-dose Day 140 | -3.4 Picogram per milliliter (pg/ml) | Standard Deviation 92.42 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 112 | 214.4 Picogram per milliliter (pg/ml) | Standard Deviation 342.45 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 84 | 122.2 Picogram per milliliter (pg/ml) | Standard Deviation 362.01 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 2H post-dose Day 1 | 45.3 Picogram per milliliter (pg/ml) | Standard Deviation 125.22 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at 1 H post-dose Day 140 | -25.0 Picogram per milliliter (pg/ml) | Standard Deviation 80.53 |
| Placebo | Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Change at Day 75 | 205.6 Picogram per milliliter (pg/ml) | Standard Deviation 302.4 |
Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Time frame: Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT-INR | 0.006 Ratio | Standard Deviation 0.0586 |
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT-INR | -0.027 Ratio | Standard Deviation 0.1078 |
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT-INR | 0.014 Ratio | Standard Deviation 0.1001 |
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT-INR | -0.022 Ratio | Standard Deviation 0.0256 |
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT-INR | -0.047 Ratio | Standard Deviation 0.0288 |
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT-INR | -0.058 Ratio | Standard Deviation 0.0776 |
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT-INR | 0.037 Ratio | Standard Deviation 0.0535 |
| RN6G 5 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT-INR | 0.995 Ratio | Standard Deviation 0.0455 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT-INR | -0.008 Ratio | Standard Deviation 0.0488 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT-INR | 0.972 Ratio | Standard Deviation 0.0436 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT-INR | -0.003 Ratio | Standard Deviation 0.0234 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT-INR | -0.027 Ratio | Standard Deviation 0.0755 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT-INR | 0.004 Ratio | Standard Deviation 0.0522 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT-INR | 0.042 Ratio | Standard Deviation 0.0697 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT-INR | -0.005 Ratio | Standard Deviation 0.0912 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT-INR | 0.047 Ratio | Standard Deviation 0.0344 |
| RN6G 10 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PT-INR | 0.085 Ratio | Standard Deviation 0.0599 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT-INR | 0.096 Ratio | Standard Deviation 0.0623 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT-INR | 0.140 Ratio | Standard Deviation 0.1231 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT-INR | 0.064 Ratio | Standard Deviation 0.1199 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT-INR | 0.106 Ratio | Standard Deviation 0.0669 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT-INR | 0.098 Ratio | Standard Deviation 0.0519 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT-INR | 0.933 Ratio | Standard Deviation 0.0871 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PT-INR | 0.055 Ratio | Standard Deviation 0.0481 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT-INR | 0.060 Ratio | Standard Deviation 0.0651 |
| RN6G 15 mg/kg | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT-INR | 0.117 Ratio | Standard Deviation 0.1076 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 56: PT-INR | 0.000 Ratio | Standard Deviation 0.1802 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: PT-INR | -0.050 Ratio | Standard Deviation 0.1077 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 112: PT-INR | -0.062 Ratio | Standard Deviation 0.1284 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 84: PT-INR | -0.060 Ratio | Standard Deviation 0.1374 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: PT-INR | -0.018 Ratio | Standard Deviation 0.1148 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 28: PT-INR | -0.050 Ratio | Standard Deviation 0.0925 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 140: PT-INR | -0.006 Ratio | Standard Deviation 0.1757 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: PT-INR | 1.017 Ratio | Standard Deviation 0.1167 |
| Placebo | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: PT-INR | 0.050 Ratio | Standard Deviation 0.1927 |
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Time frame: Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET
Population: Safety analysis set included all randomized participants who received any amount of study drug. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Baseline | 64.2 Beats per minute | Standard Deviation 6.4 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 56 | 1.2 Beats per minute | Standard Deviation 2.99 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 112 | -0.8 Beats per minute | Standard Deviation 4.02 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose day 56 | 3.0 Beats per minute | Standard Deviation 4.69 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 75 | 1.5 Beats per minute | Standard Deviation 4.64 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 103 | 2.2 Beats per minute | Standard Deviation 2.04 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 84 | 2.3 Beats per minute | Standard Deviation 3.83 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1H post-dose Day 1 | 1.7 Beats per minute | Standard Deviation 2.66 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 84 | -0.3 Beats per minute | Standard Deviation 5.89 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post dose Day 141 | 1.0 Beats per minute | Standard Deviation 3.22 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1 H post-dose Day 140 | -0.5 Beats per minute | Standard Deviation 4.37 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post-dose Day 1 | 3.5 Beats per minute | Standard Deviation 6.25 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 224/ET | -1.2 Beats per minute | Standard Deviation 6.94 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post-dose Day 2 | 0.8 Beats per minute | Standard Deviation 2.71 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 7 | 4.5 Beats per minute | Standard Deviation 3.67 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 168 | 1.7 Beats per minute | Standard Deviation 1.86 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 140 | 2.5 Beats per minute | Standard Deviation 3.99 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 14 | 1.2 Beats per minute | Standard Deviation 2.04 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 19 | 2.5 Beats per minute | Standard Deviation 5.92 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 131 | 1.8 Beats per minute | Standard Deviation 4.07 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 28 | 0.2 Beats per minute | Standard Deviation 5.53 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 28 | 6.5 Beats per minute | Standard Deviation 10.15 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post dose Day 140. | 3.2 Beats per minute | Standard Deviation 4.83 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 112 | 1.8 Beats per minute | Standard Deviation 2.86 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 45 | 3.5 Beats per minute | Standard Deviation 2.17 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 154 | 9.2 Beats per minute | Standard Deviation 3.82 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 304/ET | 1.2 Beats per minute | Standard Deviation 5.88 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post-dose Day 2 | 1.5 Beats per minute | Standard Deviation 1.97 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 112 | 1.5 Beats per minute | Standard Deviation 3.33 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 224/ET | 0.3 Beats per minute | Standard Deviation 5.01 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 56 | 1.5 Beats per minute | Standard Deviation 4.37 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Baseline | 62.8 Beats per minute | Standard Deviation 4.4 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 140 | 2.8 Beats per minute | Standard Deviation 4.07 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 45 | 2.3 Beats per minute | Standard Deviation 4.03 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose day 56 | 2.3 Beats per minute | Standard Deviation 4.13 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post dose Day 141 | 8.7 Beats per minute | Standard Deviation 3.88 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 103 | 2.5 Beats per minute | Standard Deviation 4.09 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 7 | 3.3 Beats per minute | Standard Deviation 3.08 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 75 | 5.5 Beats per minute | Standard Deviation 6.19 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1 H post-dose Day 140 | 0.8 Beats per minute | Standard Deviation 5.53 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 28 | 2.2 Beats per minute | Standard Deviation 2.56 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 28 | 2.3 Beats per minute | Standard Deviation 5.32 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 84 | 4.0 Beats per minute | Standard Deviation 3.1 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 131 | 7.2 Beats per minute | Standard Deviation 7.55 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 84 | 1.8 Beats per minute | Standard Deviation 4.31 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 168 | -0.5 Beats per minute | Standard Deviation 4.89 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1H post-dose Day 1 | -1.8 Beats per minute | Standard Deviation 4.4 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 14 | 4.3 Beats per minute | Standard Deviation 7.39 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post dose Day 140. | 4.0 Beats per minute | Standard Deviation 8.94 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 112 | 3.3 Beats per minute | Standard Deviation 5.05 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post-dose Day 1 | 1.2 Beats per minute | Standard Deviation 5.81 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 19 | 7.8 Beats per minute | Standard Deviation 7.6 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 140 | -0.8 Beats per minute | Standard Deviation 4.79 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 154 | 0.5 Beats per minute | Standard Deviation 8.73 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 168 | -6.8 Beats per minute | Standard Deviation 5.42 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 224/ET | -0.7 Beats per minute | Standard Deviation 5.99 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 304/ET | -0.2 Beats per minute | Standard Deviation 2.56 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Baseline | 66.5 Beats per minute | Standard Deviation 6.53 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1H post-dose Day 1 | -4.2 Beats per minute | Standard Deviation 5.46 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post-dose Day 1 | -2.3 Beats per minute | Standard Deviation 7.5 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post-dose Day 2 | -2.0 Beats per minute | Standard Deviation 3.74 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 7 | -4.2 Beats per minute | Standard Deviation 5.42 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 14 | 0.3 Beats per minute | Standard Deviation 4.59 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 19 | 0.0 Beats per minute | Standard Deviation 2.45 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 28 | -1.5 Beats per minute | Standard Deviation 5.72 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 28 | -2.8 Beats per minute | Standard Deviation 4.32 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 45 | 5.2 Beats per minute | Standard Deviation 7.26 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 56 | -3.7 Beats per minute | Standard Deviation 5.13 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose day 56 | 1.6 Beats per minute | Standard Deviation 10.14 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 75 | 8.0 Beats per minute | Standard Deviation 8.12 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 84 | -1.8 Beats per minute | Standard Deviation 4.17 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 84 | -2.7 Beats per minute | Standard Deviation 7.76 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 103 | 1.3 Beats per minute | Standard Deviation 1.63 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 112 | -0.2 Beats per minute | Standard Deviation 4.26 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 112 | -2.2 Beats per minute | Standard Deviation 3.19 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 131 | 2.8 Beats per minute | Standard Deviation 13.07 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1 H post-dose Day 140 | -4.5 Beats per minute | Standard Deviation 6.83 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post dose Day 140. | -2.8 Beats per minute | Standard Deviation 6.91 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post dose Day 141 | -2.0 Beats per minute | Standard Deviation 6.1 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 45 | -3.0 Beats per minute | Standard Deviation 5.73 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post dose Day 141 | 6.4 Beats per minute | Standard Deviation 4.77 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 112 | 0.2 Beats per minute | Standard Deviation 5.02 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 28 | 0.3 Beats per minute | Standard Deviation 12.04 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 28 | -1.2 Beats per minute | Standard Deviation 2.71 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post dose Day 140. | -1.0 Beats per minute | Standard Deviation 10.2 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 112 | -1.6 Beats per minute | Standard Deviation 0.89 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 19 | 1.0 Beats per minute | Standard Deviation 5.76 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 14 | 6.0 Beats per minute | Standard Deviation 6.93 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 168 | 4.8 Beats per minute | Standard Deviation 7.56 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 131 | 1.8 Beats per minute | Standard Deviation 6.94 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 7 | 4.2 Beats per minute | Standard Deviation 5.95 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 24 H post-dose Day 2 | 3.8 Beats per minute | Standard Deviation 6.4 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4 H post-dose Day 1 | 4.0 Beats per minute | Standard Deviation 7.77 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 140 | 3.2 Beats per minute | Standard Deviation 3.27 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1H post-dose Day 1 | 1.0 Beats per minute | Standard Deviation 8.83 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Baseline | 66.7 Beats per minute | Standard Deviation 5.01 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 154 | 13.5 Beats per minute | Standard Deviation 5 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 1 H post-dose Day 140 | -3.2 Beats per minute | Standard Deviation 9.09 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 84 | 2.2 Beats per minute | Standard Deviation 7.09 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 304/ET | 2.0 Beats per minute | Standard Deviation 5.66 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose Day 84 | 4.2 Beats per minute | Standard Deviation 5.12 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 75 | 6.8 Beats per minute | Standard Deviation 8.9 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at 4-8 H post-dose day 56 | 6.0 Beats per minute | Standard Deviation 9.08 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 224/ET | 0.5 Beats per minute | Standard Deviation 4.55 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at Day 103 | 6.0 Beats per minute | Standard Deviation 5.29 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate | Change at pre-dose Day 56 | 2.0 Beats per minute | Standard Deviation 5.51 |
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Time frame: Baseline, 1 and 4 hour (H) post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET
Population: Safety analysis set included all randomized participants who received any amount of study drug. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: DBP | -4.3 millimeter of mercury (mmHg) | Standard Deviation 10.15 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Pre-dose Day 84: SBP | 3.2 millimeter of mercury (mmHg) | Standard Deviation 15.05 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: SBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 7.45 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: DBP | -1.7 millimeter of mercury (mmHg) | Standard Deviation 7.84 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: DBP | -2.7 millimeter of mercury (mmHg) | Standard Deviation 8.36 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8H post-dose Day 84: SBP | 0.0 millimeter of mercury (mmHg) | Standard Deviation 9.63 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: DBP | 1.0 millimeter of mercury (mmHg) | Standard Deviation 5.33 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: SBP | 5.0 millimeter of mercury (mmHg) | Standard Deviation 11.22 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: DBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 3.01 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: SBP | 2.0 millimeter of mercury (mmHg) | Standard Deviation 13.08 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: DBP | -4.7 millimeter of mercury (mmHg) | Standard Deviation 4.13 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: SBP | -6.0 millimeter of mercury (mmHg) | Standard Deviation 9.96 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: SBP | 5.8 millimeter of mercury (mmHg) | Standard Deviation 24.04 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: SBP | -2.0 millimeter of mercury (mmHg) | Standard Deviation 12.65 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: DBP | 0.8 millimeter of mercury (mmHg) | Standard Deviation 5 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: DBP | -1.0 millimeter of mercury (mmHg) | Standard Deviation 11.51 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112:DBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 8.16 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112: SBP | -4.7 millimeter of mercury (mmHg) | Standard Deviation 8.26 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28: SBP | 7.7 millimeter of mercury (mmHg) | Standard Deviation 10.61 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: DBP | -2.2 millimeter of mercury (mmHg) | Standard Deviation 6.88 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: SBP | -6.0 millimeter of mercury (mmHg) | Standard Deviation 11.1 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: SBP | 4.3 millimeter of mercury (mmHg) | Standard Deviation 13.11 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: SBP | 1.8 millimeter of mercury (mmHg) | Standard Deviation 15.83 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: SBP | 7.3 millimeter of mercury (mmHg) | Standard Deviation 22.08 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: DBP | -1.8 millimeter of mercury (mmHg) | Standard Deviation 8.35 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: SBP | -5.3 millimeter of mercury (mmHg) | Standard Deviation 15.78 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: DBP | -6.3 millimeter of mercury (mmHg) | Standard Deviation 8.24 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: SBP | 3.7 millimeter of mercury (mmHg) | Standard Deviation 6.62 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: SBP | 7.7 millimeter of mercury (mmHg) | Standard Deviation 11.83 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: DBP | -0.8 millimeter of mercury (mmHg) | Standard Deviation 8.5 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: DBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 6.02 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: DBP | -5.0 millimeter of mercury (mmHg) | Standard Deviation 5.76 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: SBP | -0.7 millimeter of mercury (mmHg) | Standard Deviation 11.64 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: SBP | 5.0 millimeter of mercury (mmHg) | Standard Deviation 15.48 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28:DBP | 0.7 millimeter of mercury (mmHg) | Standard Deviation 6.53 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: SBP | 1.0 millimeter of mercury (mmHg) | Standard Deviation 8.56 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: DBP | -2.7 millimeter of mercury (mmHg) | Standard Deviation 7.87 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: SBP | 2.0 millimeter of mercury (mmHg) | Standard Deviation 15.13 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 84:DBP | -6.7 millimeter of mercury (mmHg) | Standard Deviation 7.97 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: DBP | 78.7 millimeter of mercury (mmHg) | Standard Deviation 7.55 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: SBP | 4.8 millimeter of mercury (mmHg) | Standard Deviation 10.82 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: DBP | -1.7 millimeter of mercury (mmHg) | Standard Deviation 11.48 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1H post-dose Day 1: SBP | 11.3 millimeter of mercury (mmHg) | Standard Deviation 10.71 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 1: DBP | -0.3 millimeter of mercury (mmHg) | Standard Deviation 7.09 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: DBP | -0.3 millimeter of mercury (mmHg) | Standard Deviation 6.12 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: SBP | -0.7 millimeter of mercury (mmHg) | Standard Deviation 19.34 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 84: DBP | -0.7 millimeter of mercury (mmHg) | Standard Deviation 8.45 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: DBP | -3.7 millimeter of mercury (mmHg) | Standard Deviation 11.48 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: DBP | 1.7 millimeter of mercury (mmHg) | Standard Deviation 5.99 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: SBP | 128.0 millimeter of mercury (mmHg) | Standard Deviation 10.58 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 1: DBP | 3.5 millimeter of mercury (mmHg) | Standard Deviation 9.38 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: DBP | 1.0 millimeter of mercury (mmHg) | Standard Deviation 8 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: DBP | -1.5 millimeter of mercury (mmHg) | Standard Deviation 8.09 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 154: SBP | -2.7 millimeter of mercury (mmHg) | Standard Deviation 8.8 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: DBP | 2.2 millimeter of mercury (mmHg) | Standard Deviation 12.04 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: DBP | -0.7 millimeter of mercury (mmHg) | Standard Deviation 5.32 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: SBP | -2.5 millimeter of mercury (mmHg) | Standard Deviation 10.43 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: DBP | 4.7 millimeter of mercury (mmHg) | Standard Deviation 8.26 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: SBP | -6.2 millimeter of mercury (mmHg) | Standard Deviation 9.43 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: DBP | 3.7 millimeter of mercury (mmHg) | Standard Deviation 9.91 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: SBP | -6.7 millimeter of mercury (mmHg) | Standard Deviation 16.44 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: DBP | -1.2 millimeter of mercury (mmHg) | Standard Deviation 6.59 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: DBP | -2.2 millimeter of mercury (mmHg) | Standard Deviation 8.95 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: DBP | -3.2 millimeter of mercury (mmHg) | Standard Deviation 10.01 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28:DBP | 0.0 millimeter of mercury (mmHg) | Standard Deviation 12.9 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: SBP | -8.8 millimeter of mercury (mmHg) | Standard Deviation 10.09 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: DBP | 5.8 millimeter of mercury (mmHg) | Standard Deviation 11.74 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1H post-dose Day 1: SBP | -5.7 millimeter of mercury (mmHg) | Standard Deviation 16.56 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: SBP | -0.8 millimeter of mercury (mmHg) | Standard Deviation 11.18 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: DBP | 0.3 millimeter of mercury (mmHg) | Standard Deviation 10.98 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: DBP | 3.3 millimeter of mercury (mmHg) | Standard Deviation 9.2 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: DBP | -0.5 millimeter of mercury (mmHg) | Standard Deviation 11.93 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28: SBP | -5.5 millimeter of mercury (mmHg) | Standard Deviation 12.29 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: SBP | 0.3 millimeter of mercury (mmHg) | Standard Deviation 12.31 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: DBP | 4.2 millimeter of mercury (mmHg) | Standard Deviation 10.82 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: SBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 9.61 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: SBP | -1.7 millimeter of mercury (mmHg) | Standard Deviation 7.34 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: SBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 17.42 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: DBP | 2.5 millimeter of mercury (mmHg) | Standard Deviation 11.2 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: SBP | -1.8 millimeter of mercury (mmHg) | Standard Deviation 16.57 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Pre-dose Day 84: SBP | -0.8 millimeter of mercury (mmHg) | Standard Deviation 8.91 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: DBP | 0.0 millimeter of mercury (mmHg) | Standard Deviation 11.51 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: DBP | -1.7 millimeter of mercury (mmHg) | Standard Deviation 8.48 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8H post-dose Day 84: SBP | -7.0 millimeter of mercury (mmHg) | Standard Deviation 12.62 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: SBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 11.29 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: SBP | -10.7 millimeter of mercury (mmHg) | Standard Deviation 18.53 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112:DBP | 0.0 millimeter of mercury (mmHg) | Standard Deviation 10.73 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: SBP | -1.2 millimeter of mercury (mmHg) | Standard Deviation 17.28 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: SBP | 128.7 millimeter of mercury (mmHg) | Standard Deviation 18.05 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112: SBP | -2.7 millimeter of mercury (mmHg) | Standard Deviation 10.25 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: DBP | 3.3 millimeter of mercury (mmHg) | Standard Deviation 10.8 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: SBP | 0.2 millimeter of mercury (mmHg) | Standard Deviation 12.59 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: SBP | -2.3 millimeter of mercury (mmHg) | Standard Deviation 16.42 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: SBP | -5.3 millimeter of mercury (mmHg) | Standard Deviation 15.47 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: DBP | 0.3 millimeter of mercury (mmHg) | Standard Deviation 12.23 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: SBP | 4.7 millimeter of mercury (mmHg) | Standard Deviation 14.88 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 304/ET: DBP | 1.3 millimeter of mercury (mmHg) | Standard Deviation 11.57 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: SBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 12.75 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 154: DBP | 2.5 millimeter of mercury (mmHg) | Standard Deviation 8.85 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 84:DBP | -3.0 millimeter of mercury (mmHg) | Standard Deviation 8.07 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 304/ET: SBP | -1.7 millimeter of mercury (mmHg) | Standard Deviation 9.07 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: DBP | 75.0 millimeter of mercury (mmHg) | Standard Deviation 10.56 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: SBP | -1.5 millimeter of mercury (mmHg) | Standard Deviation 9.29 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 84: DBP | 0.8 millimeter of mercury (mmHg) | Standard Deviation 14.76 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: SBP | -11.8 millimeter of mercury (mmHg) | Standard Deviation 7.96 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: SBP | 127.3 millimeter of mercury (mmHg) | Standard Deviation 7.37 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1H post-dose Day 1: SBP | 3.8 millimeter of mercury (mmHg) | Standard Deviation 11.7 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: SBP | 2.2 millimeter of mercury (mmHg) | Standard Deviation 9.64 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: SBP | -5.0 millimeter of mercury (mmHg) | Standard Deviation 8.29 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: SBP | -1.5 millimeter of mercury (mmHg) | Standard Deviation 7.74 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: SBP | -7.2 millimeter of mercury (mmHg) | Standard Deviation 11.84 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: SBP | -8.6 millimeter of mercury (mmHg) | Standard Deviation 8.35 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: SBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 11.76 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28: SBP | 3.6 millimeter of mercury (mmHg) | Standard Deviation 11.8 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: SBP | -1.6 millimeter of mercury (mmHg) | Standard Deviation 23.42 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: SBP | -4.5 millimeter of mercury (mmHg) | Standard Deviation 14.71 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: SBP | -0.2 millimeter of mercury (mmHg) | Standard Deviation 11.58 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: SBP | 1.8 millimeter of mercury (mmHg) | Standard Deviation 15.88 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Pre-dose Day 84: SBP | -0.3 millimeter of mercury (mmHg) | Standard Deviation 15.88 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8H post-dose Day 84: SBP | 3.8 millimeter of mercury (mmHg) | Standard Deviation 10.3 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: SBP | 5.5 millimeter of mercury (mmHg) | Standard Deviation 8.62 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: SBP | -0.5 millimeter of mercury (mmHg) | Standard Deviation 10.35 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112: SBP | -1.7 millimeter of mercury (mmHg) | Standard Deviation 11.64 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: SBP | 1.0 millimeter of mercury (mmHg) | Standard Deviation 9.75 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: SBP | -2.8 millimeter of mercury (mmHg) | Standard Deviation 8.16 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: SBP | -3.0 millimeter of mercury (mmHg) | Standard Deviation 12.81 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: SBP | -1.0 millimeter of mercury (mmHg) | Standard Deviation 13.71 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 304/ET: SBP | 0.5 millimeter of mercury (mmHg) | Standard Deviation 18.57 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: DBP | 80.3 millimeter of mercury (mmHg) | Standard Deviation 7.74 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 1: DBP | 3.0 millimeter of mercury (mmHg) | Standard Deviation 8.44 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: DBP | 0.2 millimeter of mercury (mmHg) | Standard Deviation 8.01 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: DBP | -4.7 millimeter of mercury (mmHg) | Standard Deviation 8.8 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: DBP | -2.7 millimeter of mercury (mmHg) | Standard Deviation 9.44 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: DBP | -3.7 millimeter of mercury (mmHg) | Standard Deviation 10.63 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: DBP | -5.4 millimeter of mercury (mmHg) | Standard Deviation 4.45 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: DBP | -2.8 millimeter of mercury (mmHg) | Standard Deviation 11.72 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28:DBP | 2.6 millimeter of mercury (mmHg) | Standard Deviation 4.22 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: DBP | -4.6 millimeter of mercury (mmHg) | Standard Deviation 11.99 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: DBP | -1.0 millimeter of mercury (mmHg) | Standard Deviation 5.06 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: DBP | 1.4 millimeter of mercury (mmHg) | Standard Deviation 7.2 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: SBP | -3.3 millimeter of mercury (mmHg) | Standard Deviation 8.57 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: SBP | -0.7 millimeter of mercury (mmHg) | Standard Deviation 3.33 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 154: SBP | -6.7 millimeter of mercury (mmHg) | Standard Deviation 8.24 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: DBP | -4.6 millimeter of mercury (mmHg) | Standard Deviation 5.59 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 84: DBP | -1.2 millimeter of mercury (mmHg) | Standard Deviation 11.39 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 84:DBP | 0.5 millimeter of mercury (mmHg) | Standard Deviation 10.25 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: DBP | 2.2 millimeter of mercury (mmHg) | Standard Deviation 7.96 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: DBP | -2.3 millimeter of mercury (mmHg) | Standard Deviation 5.01 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112:DBP | -1.0 millimeter of mercury (mmHg) | Standard Deviation 6.93 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: DBP | -3.4 millimeter of mercury (mmHg) | Standard Deviation 8.99 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: DBP | 1.0 millimeter of mercury (mmHg) | Standard Deviation 14.52 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: DBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 10.19 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: DBP | -6.5 millimeter of mercury (mmHg) | Standard Deviation 8.24 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: DBP | -4.5 millimeter of mercury (mmHg) | Standard Deviation 7.09 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 154: DBP | -5.5 millimeter of mercury (mmHg) | Standard Deviation 5.79 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: DBP | -4.8 millimeter of mercury (mmHg) | Standard Deviation 7 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: DBP | -3.0 millimeter of mercury (mmHg) | Standard Deviation 4.52 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 304/ET: DBP | 1.2 millimeter of mercury (mmHg) | Standard Deviation 16.41 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 1: DBP | -3.3 millimeter of mercury (mmHg) | Standard Deviation 7.26 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: DBP | 76.7 millimeter of mercury (mmHg) | Standard Deviation 5.99 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: SBP | -4.0 millimeter of mercury (mmHg) | Standard Deviation 4.15 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 84: DBP | 2.2 millimeter of mercury (mmHg) | Standard Deviation 7.66 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 304/ET: SBP | 2.3 millimeter of mercury (mmHg) | Standard Deviation 15.52 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: SBP | 5.4 millimeter of mercury (mmHg) | Standard Deviation 20.51 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: DBP | -0.5 millimeter of mercury (mmHg) | Standard Deviation 5.96 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 84:DBP | -2.0 millimeter of mercury (mmHg) | Standard Deviation 6.67 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 224/ET: SBP | 5.5 millimeter of mercury (mmHg) | Standard Deviation 9.93 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: SBP | 2.6 millimeter of mercury (mmHg) | Standard Deviation 8.56 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 154: DBP | -4.0 millimeter of mercury (mmHg) | Standard Deviation 4.97 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: DBP | 3.4 millimeter of mercury (mmHg) | Standard Deviation 4.04 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: SBP | 12.2 millimeter of mercury (mmHg) | Standard Deviation 13.2 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112: SBP | 7.4 millimeter of mercury (mmHg) | Standard Deviation 14.62 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: SBP | 0.8 millimeter of mercury (mmHg) | Standard Deviation 4.62 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: DBP | 4.4 millimeter of mercury (mmHg) | Standard Deviation 4.39 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 112: SBP | 12.8 millimeter of mercury (mmHg) | Standard Deviation 8.87 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 103: SBP | 11.4 millimeter of mercury (mmHg) | Standard Deviation 12.03 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: SBP | 2.7 millimeter of mercury (mmHg) | Standard Deviation 12.55 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 112:DBP | 1.0 millimeter of mercury (mmHg) | Standard Deviation 7.55 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8H post-dose Day 84: SBP | 7.0 millimeter of mercury (mmHg) | Standard Deviation 13.58 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Pre-dose Day 84: SBP | 10.0 millimeter of mercury (mmHg) | Standard Deviation 9.67 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: SBP | 5.2 millimeter of mercury (mmHg) | Standard Deviation 11.12 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 131: DBP | 0.0 millimeter of mercury (mmHg) | Standard Deviation 5.34 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: SBP | 6.0 millimeter of mercury (mmHg) | Standard Deviation 11.77 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: SBP | 8.2 millimeter of mercury (mmHg) | Standard Deviation 17.48 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 168: DBP | 1.0 millimeter of mercury (mmHg) | Standard Deviation 5.92 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 140: DBP | -0.4 millimeter of mercury (mmHg) | Standard Deviation 5.32 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: SBP | 3.2 millimeter of mercury (mmHg) | Standard Deviation 9.52 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: SBP | 4.3 millimeter of mercury (mmHg) | Standard Deviation 7.12 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1H post-dose Day 1: SBP | 2.5 millimeter of mercury (mmHg) | Standard Deviation 6.38 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 1 H post-dose Day 140: DBP | -2.2 millimeter of mercury (mmHg) | Standard Deviation 6.22 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28: SBP | 7.3 millimeter of mercury (mmHg) | Standard Deviation 18.69 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: SBP | -0.3 millimeter of mercury (mmHg) | Standard Deviation 9.56 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Baseline: SBP | 125.3 millimeter of mercury (mmHg) | Standard Deviation 12.19 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: DBP | -2.2 millimeter of mercury (mmHg) | Standard Deviation 5.22 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose day 56: DBP | -3.0 millimeter of mercury (mmHg) | Standard Deviation 6.44 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 56: DBP | 2.3 millimeter of mercury (mmHg) | Standard Deviation 8.73 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 45: DBP | -2.0 millimeter of mercury (mmHg) | Standard Deviation 10.97 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4-8 H post-dose Day 28:DBP | -4.5 millimeter of mercury (mmHg) | Standard Deviation 7.15 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at pre-dose Day 28: DBP | -4.8 millimeter of mercury (mmHg) | Standard Deviation 8.16 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: DBP | -3.7 millimeter of mercury (mmHg) | Standard Deviation 6.83 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: DBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 6.06 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 19: SBP | -1.3 millimeter of mercury (mmHg) | Standard Deviation 3.2 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post dose Day 140: SBP | 12.4 millimeter of mercury (mmHg) | Standard Deviation 7.44 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 7: DBP | -2.3 millimeter of mercury (mmHg) | Standard Deviation 6.47 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post-dose Day 2: DBP | -2.2 millimeter of mercury (mmHg) | Standard Deviation 8.82 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 14: SBP | 2.8 millimeter of mercury (mmHg) | Standard Deviation 7.49 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: SBP | 10.2 millimeter of mercury (mmHg) | Standard Deviation 11.99 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 4 H post-dose Day 1: DBP | -4.3 millimeter of mercury (mmHg) | Standard Deviation 4.03 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 304/ET: DBP | 2.8 millimeter of mercury (mmHg) | Standard Deviation 4.99 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 154: SBP | 0.3 millimeter of mercury (mmHg) | Standard Deviation 7.41 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at 24 H post dose Day 141: DBP | 0.6 millimeter of mercury (mmHg) | Standard Deviation 6.73 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure | Change at Day 75: DBP | -1.2 millimeter of mercury (mmHg) | Standard Deviation 6.53 |
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Time frame: Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET
Population: Safety analysis set included all randomized participants who received any amount of study drug. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post dose Day 141 | 0.00 Degree Celsius | Standard Deviation 0.21 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 75 | -0.15 Degree Celsius | Standard Deviation 0.437 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose day 56 | 0.22 Degree Celsius | Standard Deviation 0.313 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 28 | 0.18 Degree Celsius | Standard Deviation 0.204 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post dose Day 140 | 0.23 Degree Celsius | Standard Deviation 0.197 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 56 | 0.05 Degree Celsius | Standard Deviation 0.476 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 45 | 0.13 Degree Celsius | Standard Deviation 0.413 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 28 | 0.28 Degree Celsius | Standard Deviation 0.172 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post-dose Day 1 | 0.18 Degree Celsius | Standard Deviation 0.571 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 168 | 0.27 Degree Celsius | Standard Deviation 0.459 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1 H post-dose Day 140 | 0.02 Degree Celsius | Standard Deviation 0.496 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 140 | 0.10 Degree Celsius | Standard Deviation 0.352 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post-dose Day 2 | 0.22 Degree Celsius | Standard Deviation 0.204 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Baseline | 36.40 Degree Celsius | Standard Deviation 0.228 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 131 | 0.18 Degree Celsius | Standard Deviation 0.387 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 112 | 0.03 Degree Celsius | Standard Deviation 0.437 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 7 | 0.15 Degree Celsius | Standard Deviation 0.226 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1H post-dose Day 1 | 0.30 Degree Celsius | Standard Deviation 0.405 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 112 | -0.08 Degree Celsius | Standard Deviation 0.512 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 103 | 0.05 Degree Celsius | Standard Deviation 0.394 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 14 | 0.37 Degree Celsius | Standard Deviation 0.35 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 224/ET | 0.03 Degree Celsius | Standard Deviation 0.446 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 84 | -0.13 Degree Celsius | Standard Deviation 0.665 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 84 | -0.03 Degree Celsius | Standard Deviation 0.216 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 19 | 0.43 Degree Celsius | Standard Deviation 0.234 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post-dose Day 2 | 0.12 Degree Celsius | Standard Deviation 0.232 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Baseline | 36.72 Degree Celsius | Standard Deviation 0.256 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1H post-dose Day 1 | 0.10 Degree Celsius | Standard Deviation 0.253 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post-dose Day 1 | 0.08 Degree Celsius | Standard Deviation 0.133 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 7 | 0.05 Degree Celsius | Standard Deviation 0.315 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 14 | -0.03 Degree Celsius | Standard Deviation 0.327 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 19 | -0.12 Degree Celsius | Standard Deviation 0.271 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 28 | -0.10 Degree Celsius | Standard Deviation 0.283 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 28 | 0.15 Degree Celsius | Standard Deviation 0.339 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 45 | 0.12 Degree Celsius | Standard Deviation 0.483 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 56 | 0.08 Degree Celsius | Standard Deviation 0.366 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose day 56 | 0.13 Degree Celsius | Standard Deviation 0.273 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 75 | 0.07 Degree Celsius | Standard Deviation 0.333 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 84 | -0.03 Degree Celsius | Standard Deviation 0.32 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 84 | 0.00 Degree Celsius | Standard Deviation 0.167 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 103 | -0.08 Degree Celsius | Standard Deviation 0.462 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 112 | 0.12 Degree Celsius | Standard Deviation 0.279 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 112 | 0.12 Degree Celsius | Standard Deviation 0.387 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 131 | 0.02 Degree Celsius | Standard Deviation 0.458 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 140 | -0.05 Degree Celsius | Standard Deviation 0.432 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1 H post-dose Day 140 | 0.08 Degree Celsius | Standard Deviation 0.407 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post dose Day 140 | 0.05 Degree Celsius | Standard Deviation 0.428 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post dose Day 141 | 0.08 Degree Celsius | Standard Deviation 0.248 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 154 | 0.07 Degree Celsius | Standard Deviation 0.266 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 168 | -0.12 Degree Celsius | Standard Deviation 0.293 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 224/ET | 0.07 Degree Celsius | Standard Deviation 0.234 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 304/ET | -0.10 Degree Celsius | Standard Deviation 0.283 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 7 | -0.40 Degree Celsius | Standard Deviation 0.405 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 84 | 0.02 Degree Celsius | Standard Deviation 0.147 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 14 | 0.08 Degree Celsius | Standard Deviation 0.117 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 154 | -0.25 Degree Celsius | Standard Deviation 0.414 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 84 | 0.03 Degree Celsius | Standard Deviation 0.103 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 103 | -0.10 Degree Celsius | Standard Deviation 0.219 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 112 | -0.15 Degree Celsius | Standard Deviation 0.274 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 112 | -0.22 Degree Celsius | Standard Deviation 0.293 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post-dose Day 2 | -0.32 Degree Celsius | Standard Deviation 0.371 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 168 | -0.18 Degree Celsius | Standard Deviation 0.264 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 131 | -0.14 Degree Celsius | Standard Deviation 0.288 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 140 | -0.07 Degree Celsius | Standard Deviation 0.207 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post-dose Day 1 | 0.03 Degree Celsius | Standard Deviation 0.207 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Baseline | 36.87 Degree Celsius | Standard Deviation 0.082 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1 H post-dose Day 140 | -0.03 Degree Celsius | Standard Deviation 0.197 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 304/ET | -0.10 Degree Celsius | Standard Deviation 0.167 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post dose Day 140 | -0.12 Degree Celsius | Standard Deviation 0.248 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 28 | 0.00 Degree Celsius | Standard Deviation 0.158 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1H post-dose Day 1 | -0.10 Degree Celsius | Standard Deviation 0.19 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 45 | -0.06 Degree Celsius | Standard Deviation 0.195 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 28 | -0.02 Degree Celsius | Standard Deviation 0.172 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 224/ET | -0.07 Degree Celsius | Standard Deviation 0.288 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 56 | 0.03 Degree Celsius | Standard Deviation 0.175 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post dose Day 141 | -0.18 Degree Celsius | Standard Deviation 0.183 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose day 56 | 0.12 Degree Celsius | Standard Deviation 0.084 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 19 | 0.04 Degree Celsius | Standard Deviation 0.288 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 75 | -0.06 Degree Celsius | Standard Deviation 0.279 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 140 | -0.02 Degree Celsius | Standard Deviation 0.311 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 224/ET | 0.03 Degree Celsius | Standard Deviation 0.472 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 56 | 0.07 Degree Celsius | Standard Deviation 0.35 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 84 | -0.10 Degree Celsius | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 19 | -0.02 Degree Celsius | Standard Deviation 0.183 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 45 | 0.03 Degree Celsius | Standard Deviation 0.516 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1 H post-dose Day 140 | -0.30 Degree Celsius | Standard Deviation 0.224 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 84 | 0.10 Degree Celsius | Standard Deviation 0.274 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 7 | 0.00 Degree Celsius | Standard Deviation 0.276 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 154 | 0.00 Degree Celsius | Standard Deviation 0.141 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 1H post-dose Day 1 | 0.08 Degree Celsius | Standard Deviation 0.183 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 103 | -0.06 Degree Celsius | Standard Deviation 0.251 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 14 | 0.05 Degree Celsius | Standard Deviation 0.243 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Baseline | 36.72 Degree Celsius | Standard Deviation 0.397 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 75 | -0.28 Degree Celsius | Standard Deviation 0.383 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 112 | -0.20 Degree Celsius | Standard Deviation 0.292 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post-dose Day 2 | -0.08 Degree Celsius | Standard Deviation 0.515 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 304/ET | -0.08 Degree Celsius | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 24 H post dose Day 141 | -0.14 Degree Celsius | Standard Deviation 0.365 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 112 | 0.06 Degree Celsius | Standard Deviation 0.336 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post dose Day 140 | -0.14 Degree Celsius | Standard Deviation 0.27 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose day 56 | 0.00 Degree Celsius | Standard Deviation 0.436 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4-8 H post-dose Day 28 | 0.03 Degree Celsius | Standard Deviation 0.186 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 131 | -0.04 Degree Celsius | Standard Deviation 0.261 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at 4 H post-dose Day 1 | 0.17 Degree Celsius | Standard Deviation 0.327 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at Day 168 | 0.12 Degree Celsius | Standard Deviation 0.192 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature | Change at pre-dose Day 28 | -0.17 Degree Celsius | Standard Deviation 0.294 |
Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Time frame: Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET
Population: Safety analysis set included all randomized participants who received any amount of study drug. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 103 | -0.60 Kilogram | Standard Deviation 4.787 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 140 | 1.06 Kilogram | Standard Deviation 0.833 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 112 | 0.67 Kilogram | Standard Deviation 1.118 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 28 | 0.46 Kilogram | Standard Deviation 0.749 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 131 | 1.35 Kilogram | Standard Deviation 1.354 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 224/ ET | 0.85 Kilogram | Standard Deviation 0.976 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 45 | 0.71 Kilogram | Standard Deviation 1.654 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Baseline | 81.74 Kilogram | Standard Deviation 9.975 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 56 | 0.72 Kilogram | Standard Deviation 1.425 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 19 | 0.25 Kilogram | Standard Deviation 0.709 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 168 | 1.74 Kilogram | Standard Deviation 2.723 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 75 | 0.60 Kilogram | Standard Deviation 1.464 |
| RN6G 5 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 84 | 0.63 Kilogram | Standard Deviation 1.538 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 45 | -0.49 Kilogram | Standard Deviation 2.298 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 19 | -0.05 Kilogram | Standard Deviation 1.588 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 168 | -1.35 Kilogram | Standard Deviation 4.393 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 103 | -0.75 Kilogram | Standard Deviation 3.213 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 224/ ET | -1.97 Kilogram | Standard Deviation 4.284 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 154 | -3.78 Kilogram | Standard Deviation 8.246 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 56 | -0.99 Kilogram | Standard Deviation 2.371 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 112 | 0.05 Kilogram | Standard Deviation 3.638 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 140 | -0.36 Kilogram | Standard Deviation 4.233 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 131 | -0.43 Kilogram | Standard Deviation 4.197 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 84 | -0.54 Kilogram | Standard Deviation 3.194 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 28 | -0.12 Kilogram | Standard Deviation 2.098 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 304/ET | 0.71 Kilogram | Standard Deviation 6.545 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Baseline | 85.85 Kilogram | Standard Deviation 8.443 |
| RN6G 10 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 75 | -0.46 Kilogram | Standard Deviation 3.267 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 45 | 0.52 Kilogram | Standard Deviation 0.899 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Baseline | 78.58 Kilogram | Standard Deviation 12.497 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 19 | 0.09 Kilogram | Standard Deviation 1.33 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 28 | 0.02 Kilogram | Standard Deviation 1.172 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 56 | -1.21 Kilogram | Standard Deviation 2.942 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 75 | 0.48 Kilogram | Standard Deviation 0.883 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 84 | -0.16 Kilogram | Standard Deviation 0.943 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 103 | 0.22 Kilogram | Standard Deviation 1.249 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 112 | -0.05 Kilogram | Standard Deviation 0.731 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 131 | -0.08 Kilogram | Standard Deviation 0.646 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 140 | -0.46 Kilogram | Standard Deviation 1.248 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 154 | -0.57 Kilogram | Standard Deviation 1.301 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 168 | -0.84 Kilogram | Standard Deviation 1.237 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 224/ ET | 1.49 Kilogram | Standard Deviation 4.376 |
| RN6G 15 mg/kg | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 304/ET | 3.04 Kilogram | Standard Deviation 4.327 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 140 | 1.37 Kilogram | Standard Deviation 1.708 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 75 | 0.98 Kilogram | Standard Deviation 0.641 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 224/ ET | 1.42 Kilogram | Standard Deviation 1.679 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 154 | 1.03 Kilogram | Standard Deviation 1.464 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 56 | 0.52 Kilogram | Standard Deviation 0.616 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 45 | 0.36 Kilogram | Standard Deviation 1.219 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Baseline | 80.14 Kilogram | Standard Deviation 21.43 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 168 | 1.26 Kilogram | Standard Deviation 1.312 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 28 | 0.29 Kilogram | Standard Deviation 0.661 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 112 | 1.43 Kilogram | Standard Deviation 1.097 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 19 | 0.93 Kilogram | Standard Deviation 0.945 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 131 | 1.67 Kilogram | Standard Deviation 1.159 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 103 | 1.23 Kilogram | Standard Deviation 1.49 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 84 | 0.99 Kilogram | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight | Change at Day 304/ET | 0.60 Kilogram | Standard Deviation 0.678 |
Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
QT interval corrected using the Fridericia formula (QTcF) \>=500 msec; Maximum Change from Baseline in QTcF at Borderline \>=30 msec to \<60 msec and Prolonged \>=60 msec.
Time frame: Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcF | -5.22 Millisecond (msec) | Standard Deviation 8.005 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcF | -2.67 Millisecond (msec) | Standard Deviation 7.598 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcF | 1.50 Millisecond (msec) | Standard Deviation 14.898 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcF | -3.17 Millisecond (msec) | Standard Deviation 7.001 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcF | -2.28 Millisecond (msec) | Standard Deviation 9.488 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcF | -4.39 Millisecond (msec) | Standard Deviation 6.533 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcF | -4.72 Millisecond (msec) | Standard Deviation 15.874 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcF | 0.56 Millisecond (msec) | Standard Deviation 8.035 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcF | -2.22 Millisecond (msec) | Standard Deviation 13.404 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcF | -8.56 Millisecond (msec) | Standard Deviation 16.363 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcF | -1.39 Millisecond (msec) | Standard Deviation 10.438 |
| RN6G 5 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcF | 414.22 Millisecond (msec) | Standard Deviation 13.474 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcF | 427.89 Millisecond (msec) | Standard Deviation 21.462 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcF | -12.06 Millisecond (msec) | Standard Deviation 14.565 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcF | -11.22 Millisecond (msec) | Standard Deviation 11.485 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcF | -3.28 Millisecond (msec) | Standard Deviation 8.51 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcF | -5.89 Millisecond (msec) | Standard Deviation 10.681 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcF | -0.11 Millisecond (msec) | Standard Deviation 8.614 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcF | -1.22 Millisecond (msec) | Standard Deviation 12.523 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcF | -9.72 Millisecond (msec) | Standard Deviation 14.22 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcF | -6.06 Millisecond (msec) | Standard Deviation 9.799 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcF | -15.83 Millisecond (msec) | Standard Deviation 36.907 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcF | -8.78 Millisecond (msec) | Standard Deviation 13.48 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QTcF | -6.72 Millisecond (msec) | Standard Deviation 14.685 |
| RN6G 10 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcF | -1.50 Millisecond (msec) | Standard Deviation 4.732 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcF | 12.72 Millisecond (msec) | Standard Deviation 8.172 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcF | 420.56 Millisecond (msec) | Standard Deviation 20.579 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcF | 3.06 Millisecond (msec) | Standard Deviation 8.762 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcF | 1.50 Millisecond (msec) | Standard Deviation 13.328 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcF | 1.78 Millisecond (msec) | Standard Deviation 15.022 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcF | 7.11 Millisecond (msec) | Standard Deviation 19.452 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcF | 6.11 Millisecond (msec) | Standard Deviation 20.435 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcF | 0.78 Millisecond (msec) | Standard Deviation 8.275 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcF | 8.61 Millisecond (msec) | Standard Deviation 7.672 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcF | 10.61 Millisecond (msec) | Standard Deviation 11.174 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcF | 7.94 Millisecond (msec) | Standard Deviation 18.671 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcF | 1.94 Millisecond (msec) | Standard Deviation 16.996 |
| RN6G 15 mg/kg | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QTcF | -7.39 Millisecond (msec) | Standard Deviation 21.754 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 84: QTcF | 19.00 Millisecond (msec) | Standard Deviation 24.226 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post dose Day 140: QTcF | 11.60 Millisecond (msec) | Standard Deviation 19.991 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 56: QTcF | 6.44 Millisecond (msec) | Standard Deviation 15.93 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 28: QTcF | -2.06 Millisecond (msec) | Standard Deviation 8.41 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Baseline: QTcF | 412.06 Millisecond (msec) | Standard Deviation 20.201 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 168: QTcF | 8.40 Millisecond (msec) | Standard Deviation 21.483 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 4 H post-dose Day 1: QTcF | 9.50 Millisecond (msec) | Standard Deviation 28.659 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 1: QTcF | 3.86 Millisecond (msec) | Standard Deviation 13.329 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 304/ET: QTcF | 11.50 Millisecond (msec) | Standard Deviation 18.165 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at Day 224/ET: QTcF | 10.94 Millisecond (msec) | Standard Deviation 17.055 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at 1 H post-dose Day 140: QTcF | 14.13 Millisecond (msec) | Standard Deviation 15.604 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 140: QTcF | 8.87 Millisecond (msec) | Standard Deviation 23.092 |
| Placebo | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | Change at pre-dose Day 112: QTcF | 25.80 Millisecond (msec) | Standard Deviation 39.012 |
Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923)
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | Day 1 | 142.9 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 12 |
| RN6G 5 mg/kg | Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | Day 140 | 185.1 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 16 |
| RN6G 10 mg/kg | Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | Day 140 | 439.8 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 15 |
| RN6G 10 mg/kg | Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | Day 1 | 283.4 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 18 |
| RN6G 15 mg/kg | Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | Day 1 | 524.1 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 66 |
| RN6G 15 mg/kg | Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | Day 140 | 691.7 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 12 |
Mean Residence Time (MRT) of RN6G (PF-04382923)
The mean total time drug resides in the body.
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RN6G 5 mg/kg | Mean Residence Time (MRT) of RN6G (PF-04382923) | 818.1 Hour | Standard Deviation 182.15 |
| RN6G 10 mg/kg | Mean Residence Time (MRT) of RN6G (PF-04382923) | 1274 Hour | Standard Deviation 352.28 |
| RN6G 15 mg/kg | Mean Residence Time (MRT) of RN6G (PF-04382923) | 1121 Hour | Standard Deviation 135.38 |
Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923)
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RN6G 5 mg/kg | Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) | 38.43 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 40 |
| RN6G 10 mg/kg | Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) | 119.7 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| RN6G 15 mg/kg | Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) | 201.5 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time frame: Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 3048.1 percent change | Standard Deviation 934.03 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 1283.4 percent change | Standard Deviation 428.98 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 5736.6 percent change | Standard Deviation 2367.32 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 6750.1 percent change | Standard Deviation 1605.57 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 1836.7 percent change | Standard Deviation 528.74 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 9035.4 percent change | Standard Deviation 2212.53 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 8153.4 percent change | Standard Deviation 3691.2 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 13778.6 percent change | Standard Deviation 4413.73 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 6632.8 percent change | Standard Deviation 2095.25 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 6536.9 percent change | Standard Deviation 1533.6 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 2129.1 percent change | Standard Deviation 971.74 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 8274.4 percent change | Standard Deviation 2373.14 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 4104.0 percent change | Standard Deviation 781.38 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 7539.0 percent change | Standard Deviation 2097.66 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 4001.5 percent change | Standard Deviation 1313.42 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 10332.3 percent change | Standard Deviation 2454.3 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 7033.1 percent change | Standard Deviation 1783.12 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 9742.8 percent change | Standard Deviation 1628.75 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 838.8 percent change | Standard Deviation 262.62 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 8033.3 percent change | Standard Deviation 2202.15 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 5034.2 percent change | Standard Deviation 1396.44 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 2277.4 percent change | Standard Deviation 870.42 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | 1263.2 percent change | Standard Deviation 640.49 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 13326.7 percent change | Standard Deviation 1838.41 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 10287.0 percent change | Standard Deviation 2294.92 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 12858.0 percent change | Standard Deviation 1914.67 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 12713.5 percent change | Standard Deviation 2035.1 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 11719.8 percent change | Standard Deviation 2354.18 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 5332.4 percent change | Standard Deviation 437.02 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 13197.8 percent change | Standard Deviation 1567.68 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 9991.6 percent change | Standard Deviation 4745.47 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 10766.1 percent change | Standard Deviation 2561.52 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 9483.1 percent change | Standard Deviation 2136.77 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 1051.5 percent change | Standard Deviation 230.65 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 8124.3 percent change | Standard Deviation 1400.09 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | 12461.9 percent change | Standard Deviation 1481.16 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 6169.0 percent change | Standard Deviation 996.4 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 660.9 percent change | Standard Deviation 101.2 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 15838.7 percent change | Standard Deviation 2208.15 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 4501.8 percent change | Standard Deviation 758.64 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 4228.9 percent change | Standard Deviation 1141.96 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 9614.6 percent change | Standard Deviation 1371.1 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 12606.4 percent change | Standard Deviation 1626.29 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 7229.3 percent change | Standard Deviation 1982.4 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 1649.8 percent change | Standard Deviation 190.06 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 12296.0 percent change | Standard Deviation 1777.75 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 9132.2 percent change | Standard Deviation 1770.33 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 752.8 percent change | Standard Deviation 247.2 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 1082.6 percent change | Standard Deviation 225.11 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 1509.3 percent change | Standard Deviation 255.86 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 5328.4 percent change | Standard Deviation 422.35 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 11658.5 percent change | Standard Deviation 2346.26 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 8606.3 percent change | Standard Deviation 2099.47 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 7485.9 percent change | Standard Deviation 2422.75 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 11600.4 percent change | Standard Deviation 1173.09 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 9938.9 percent change | Standard Deviation 2032.57 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 12933.0 percent change | Standard Deviation 1384.7 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 11153.8 percent change | Standard Deviation 978.44 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 14043.1 percent change | Standard Deviation 3217.61 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 13528.7 percent change | Standard Deviation 1209.21 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 17840.0 percent change | Standard Deviation 3578.16 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 16216.1 percent change | Standard Deviation 2105.17 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 16473.9 percent change | Standard Deviation 3063.74 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 17173.8 percent change | Standard Deviation 2625.79 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 17656.9 percent change | Standard Deviation 7083.3 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 19190.4 percent change | Standard Deviation 4117.8 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | 22722.9 percent change | Standard Deviation 2317.53 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 17703.0 percent change | Standard Deviation 3291.42 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 6880.8 percent change | Standard Deviation 2087.34 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | 1603.7 percent change | Standard Deviation 481.43 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 3.2 percent change | Standard Deviation 12.13 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | -11.2 percent change | Standard Deviation 9.09 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | -2.8 percent change | Standard Deviation 23.72 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 1.0 percent change | Standard Deviation 22.07 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 1.8 percent change | Standard Deviation 12.92 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | -9.6 percent change | Standard Deviation 13.47 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | -0.7 percent change | Standard Deviation 8.35 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 6.5 percent change | Standard Deviation 15.76 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | 10.9 percent change | Standard Deviation 32.02 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | -7.8 percent change | Standard Deviation 15.61 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | -2.1 percent change | Standard Deviation 5.38 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 14.5 percent change | Standard Deviation 35.7 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | -12.7 percent change | Standard Deviation 13.89 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | -1.0 percent change | Standard Deviation 7.54 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | -0.4 percent change | Standard Deviation 10.07 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 4.9 percent change | Standard Deviation 23.25 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 0.4 percent change | Standard Deviation 9.79 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 16.6 percent change | Standard Deviation 51.02 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | -6.4 percent change | Standard Deviation 15.2 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | -4.5 percent change | Standard Deviation 16.16 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | -5.3 percent change | Standard Deviation 22.33 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | -1.5 percent change | Standard Deviation 18.15 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | -3.5 percent change | Standard Deviation 28.74 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | -12.5 percent change | Standard Deviation 9.43 |
Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time frame: Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 43.0 percent change | Standard Deviation 20.81 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 257.8 percent change | Standard Deviation 101.75 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 83.2 percent change | Standard Deviation 46.16 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 111.1 percent change | Standard Deviation 25.89 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 15.9 percent change | Standard Deviation 14.37 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 337.7 percent change | Standard Deviation 67.82 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 129.8 percent change | Standard Deviation 71.07 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 360.6 percent change | Standard Deviation 70.15 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 92.5 percent change | Standard Deviation 17.6 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 278.1 percent change | Standard Deviation 163.6 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 306.4 percent change | Standard Deviation 111.88 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 264.4 percent change | Standard Deviation 55.03 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 55.8 percent change | Standard Deviation 34.06 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 119.7 percent change | Standard Deviation 30.44 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 59.7 percent change | Standard Deviation 38.36 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 397.0 percent change | Standard Deviation 70.71 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 87.8 percent change | Standard Deviation 38.89 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 168.4 percent change | Standard Deviation 41.44 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 199.0 percent change | Standard Deviation 74.28 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 128.9 percent change | Standard Deviation 42.92 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 77.0 percent change | Standard Deviation 16.8 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 29.7 percent change | Standard Deviation 37.85 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | 15.4 percent change | Standard Deviation 66.96 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 394.6 percent change | Standard Deviation 196.64 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 146.3 percent change | Standard Deviation 146.97 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 207.3 percent change | Standard Deviation 159.23 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 345.7 percent change | Standard Deviation 201.63 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 207.4 percent change | Standard Deviation 176.39 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 461.6 percent change | Standard Deviation 175.95 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 249.0 percent change | Standard Deviation 204.05 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 185.8 percent change | Standard Deviation 164.1 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 176.4 percent change | Standard Deviation 159.42 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 164.3 percent change | Standard Deviation 114.69 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 254.3 percent change | Standard Deviation 104.05 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 121.1 percent change | Standard Deviation 132.7 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | 241.5 percent change | Standard Deviation 196.56 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 87.2 percent change | Standard Deviation 92.62 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 163.7 percent change | Standard Deviation 102.35 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 539.2 percent change | Standard Deviation 291.07 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 36.5 percent change | Standard Deviation 57.79 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 27.1 percent change | Standard Deviation 74.59 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 118.9 percent change | Standard Deviation 116.56 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 459.8 percent change | Standard Deviation 234.24 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 102.2 percent change | Standard Deviation 74.51 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 341.8 percent change | Standard Deviation 174.55 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 172.1 percent change | Standard Deviation 141.94 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 163.7 percent change | Standard Deviation 37.92 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 340.2 percent change | Standard Deviation 133.1 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 412.7 percent change | Standard Deviation 98.9 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 545.8 percent change | Standard Deviation 131.45 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 708.5 percent change | Standard Deviation 200.76 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 306.5 percent change | Standard Deviation 45.29 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 153.3 percent change | Standard Deviation 25.6 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 157.6 percent change | Standard Deviation 103.15 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 267.5 percent change | Standard Deviation 59.75 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 220.4 percent change | Standard Deviation 62.44 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 314.3 percent change | Standard Deviation 75.17 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 224.2 percent change | Standard Deviation 40.97 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 315.3 percent change | Standard Deviation 127.45 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 275.2 percent change | Standard Deviation 92.55 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 393.6 percent change | Standard Deviation 66.08 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 297.3 percent change | Standard Deviation 48.94 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 553.7 percent change | Standard Deviation 122.06 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 637.8 percent change | Standard Deviation 146.28 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 781.5 percent change | Standard Deviation 165.36 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 889.4 percent change | Standard Deviation 267.61 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | 506.2 percent change | Standard Deviation 142.03 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 366.6 percent change | Standard Deviation 91.33 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 102.6 percent change | Standard Deviation 41.52 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | 11.0 percent change | Standard Deviation 12.78 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H post-dose Day 1 | 10.4 percent change | Standard Deviation 12.86 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | -28.8 percent change | Standard Deviation 33.79 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | -10.7 percent change | Standard Deviation 36.98 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | -7.7 percent change | Standard Deviation 30.53 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 0.5 percent change | Standard Deviation 23.12 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | -4.9 percent change | Standard Deviation 53.65 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | -2.6 percent change | Standard Deviation 18.74 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 20.9 percent change | Standard Deviation 49.01 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | -38.8 percent change | Standard Deviation 22.12 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | -31.3 percent change | Standard Deviation 20.95 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 21.2 percent change | Standard Deviation 47.33 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 8.2 percent change | Standard Deviation 68.87 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | -32.3 percent change | Standard Deviation 22.75 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 19.6 percent change | Standard Deviation 58.46 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | -9.8 percent change | Standard Deviation 31.29 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | -21.1 percent change | Standard Deviation 25.48 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | -7.0 percent change | Standard Deviation 20.63 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 0.2 percent change | Standard Deviation 68.99 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | -20.2 percent change | Standard Deviation 21.83 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | -16.7 percent change | Standard Deviation 29.36 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | -22.8 percent change | Standard Deviation 27.34 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | -24.0 percent change | Standard Deviation 24.14 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | -12.4 percent change | Standard Deviation 34.64 |
| Placebo | Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | -23.6 percent change | Standard Deviation 27.01 |
Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time frame: Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Number Analyzed signifies number of participants evaluated for given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 6096.9 Percent change | Standard Deviation 2660.58 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 1835.9 Percent change | Standard Deviation 859.97 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 12401.6 Percent change | Standard Deviation 5938.63 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 16323.4 Percent change | Standard Deviation 6890.74 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 3168.7 Percent change | Standard Deviation 1297.49 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 17418.4 Percent change | Standard Deviation 7204.24 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 17643.7 Percent change | Standard Deviation 7989.43 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 27212.1 Percent change | Standard Deviation 12018.62 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 14458.4 Percent change | Standard Deviation 7747.84 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 11999.3 Percent change | Standard Deviation 5344.01 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percentage change at 4 H post-dose Day 1 | 2899.5 Percent change | Standard Deviation 1575.11 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 15067.2 Percent change | Standard Deviation 6922.6 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 8156.5 Percent change | Standard Deviation 3005.78 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 19415.4 Percent change | Standard Deviation 9203.47 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 8930.3 Percent change | Standard Deviation 3978.36 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 18171.1 Percent change | Standard Deviation 7481.91 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 14815.6 Percent change | Standard Deviation 6477.51 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 20902.9 Percent change | Standard Deviation 8509.92 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 1194.4 Percent change | Standard Deviation 541.02 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 17482.8 Percent change | Standard Deviation 6740.53 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 10497.3 Percent change | Standard Deviation 4494.06 |
| RN6G 5 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 7954.0 Percent change | Standard Deviation 5003.96 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | 3182.9 Percent change | Standard Deviation 2499.39 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 27192.5 Percent change | Standard Deviation 19768.55 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 21128.7 Percent change | Standard Deviation 14305.48 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 28726.4 Percent change | Standard Deviation 20620.23 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 25462.2 Percent change | Standard Deviation 18562.61 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 26653.1 Percent change | Standard Deviation 19128.49 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 9771.3 Percent change | Standard Deviation 6115.66 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 31839.9 Percent change | Standard Deviation 22850.11 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 26584.4 Percent change | Standard Deviation 19667.93 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 26639.1 Percent change | Standard Deviation 19545.03 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 22214.1 Percent change | Standard Deviation 16132.62 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 1682.9 Percent change | Standard Deviation 1332.55 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 16692.0 Percent change | Standard Deviation 11490.17 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | 37731.7 Percent change | Standard Deviation 28276.18 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 13136.7 Percent change | Standard Deviation 9098.67 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 1032.9 Percent change | Standard Deviation 860.01 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 36042.0 Percent change | Standard Deviation 25934.3 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 8714.5 Percent change | Standard Deviation 5831.88 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 9003.9 Percent change | Standard Deviation 7319.06 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 25626.3 Percent change | Standard Deviation 16350.32 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 26342.6 Percent change | Standard Deviation 19070.4 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 16396.4 Percent change | Standard Deviation 11269.8 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percentage change at 4 H post-dose Day 1 | 2044.5 Percent change | Standard Deviation 1595.93 |
| RN6G 10 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 29483.6 Percent change | Standard Deviation 20874.07 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | 40069.0 Percent change | Standard Deviation 6897.78 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 1973.6 Percent change | Standard Deviation 911.19 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 2805.4 Percent change | Standard Deviation 1272.35 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percentage change at 4 H post-dose Day 1 | 3937.1 Percent change | Standard Deviation 1079.28 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 18931.0 Percent change | Standard Deviation 534.93 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 47008.5 Percent change | Standard Deviation 3530.28 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | 35595.3 Percent change | Standard Deviation 3776.71 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | 28850.5 Percent change | Standard Deviation 7352.55 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 55139.0 Percent change | Standard Deviation 10148.46 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 49171.9 Percent change | Standard Deviation 10668.22 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 74636.0 Percent change | Standard Deviation 11949.05 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 60045.8 Percent change | Standard Deviation 2947.55 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 78724.0 Percent change | Standard Deviation 16617.7 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 70458.8 Percent change | Standard Deviation 8749.39 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | 84383.9 Percent change | Standard Deviation 3636.46 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 77175.0 Percent change | Standard Deviation 4729.87 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | 70123.0 Percent change | Standard Deviation 7885.1 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | 68054.8 Percent change | Standard Deviation 6441.82 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | 76896.5 Percent change | Standard Deviation 7656.04 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | 80464.2 Percent change | Standard Deviation 11546.49 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | 95456.8 Percent change | Standard Deviation 14665.51 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | 80845.7 Percent change | Standard Deviation 10646.37 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | 28846.0 Percent change | Standard Deviation 8155.08 |
| RN6G 15 mg/kg | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | 6063.6 Percent change | Standard Deviation 1598.08 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percentage change at 4 H post-dose Day 1 | 14.5 Percent change | Standard Deviation 61.22 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H Post dose Day 140 | -25.9 Percent change | Standard Deviation 21.26 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 56 | 20.9 Percent change | Standard Deviation 120.63 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 45 | 19.0 Percent change | Standard Deviation 84.63 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 2 H post-dose Day 1 | 17.7 Percent change | Standard Deviation 37.96 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 4 H Post dose Day 140 | -29.4 Percent change | Standard Deviation 24.61 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 28 | -3.3 Percent change | Standard Deviation 72.57 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 19 | -13.2 Percent change | Standard Deviation 18.08 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 304 / ET | -31.6 Percent change | Standard Deviation 27.03 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 141 | -11.0 Percent change | Standard Deviation 30.66 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 14 | -12.4 Percent change | Standard Deviation 20.1 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 224 | -22.2 Percent change | Standard Deviation 27.76 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 154 | -21.2 Percent change | Standard Deviation 14.56 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 7 | 3.1 Percent change | Standard Deviation 13.89 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 2 | 4.3 Percent change | Standard Deviation 29.32 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 131 | -6.5 Percent change | Standard Deviation 28.29 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H post-dose Day 1 | 3.8 Percent change | Standard Deviation 21.25 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Pre-dose Day 140 | 6.8 Percent change | Standard Deviation 25.29 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 112 | 75.8 Percent change | Standard Deviation 138.85 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 103 | 48.2 Percent change | Standard Deviation 120.26 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 168 | -10.1 Percent change | Standard Deviation 29.15 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at 1 H Post dose Day 140 | -2.3 Percent change | Standard Deviation 23.04 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 84 | 51.2 Percent change | Standard Deviation 124.25 |
| Placebo | Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET | Percent change at Day 75 | 72.3 Percent change | Standard Deviation 122.02 |
Plasma Concentration (Css) at Steady State of RN6G (PF-04382923)
Css is the concentration of the drug at the state when the amount of drug administered is equal to the amount of drug eliminated.
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RN6G 5 mg/kg | Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) | 74.75 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| RN6G 10 mg/kg | Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) | 208.7 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 14 |
| RN6G 15 mg/kg | Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) | 317.2 Microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 16 |
Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RN6G 5 mg/kg | Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) | 25.14 Hour | Standard Deviation 5.0774 |
| RN6G 10 mg/kg | Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) | 42.00 Hour | Standard Deviation 6.6321 |
| RN6G 15 mg/kg | Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) | 38.10 Hour | Standard Deviation 4.9738 |
Systemic Clearance (CL) of RN6G (PF-04382923)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RN6G 5 mg/kg | Systemic Clearance (CL) of RN6G (PF-04382923) | 0.09954 Milliliter per hour per kilogram | Geometric Coefficient of Variation 20 |
| RN6G 10 mg/kg | Systemic Clearance (CL) of RN6G (PF-04382923) | 0.07129 Milliliter per hour per kilogram | Geometric Coefficient of Variation 14 |
| RN6G 15 mg/kg | Systemic Clearance (CL) of RN6G (PF-04382923) | 0.07036 Milliliter per hour per kilogram | Geometric Coefficient of Variation 16 |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923)
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RN6G 5 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | Day 140 | 1.77 Hour |
| RN6G 5 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | Day 1 | 1.49 Hour |
| RN6G 10 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | Day 1 | 2.06 Hour |
| RN6G 10 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | Day 140 | 2.05 Hour |
| RN6G 15 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | Day 1 | 2.17 Hour |
| RN6G 15 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | Day 140 | 1.32 Hour |
Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Population: Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here Overall Number of participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RN6G 5 mg/kg | Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) | 79.52 Milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 23 |
| RN6G 10 mg/kg | Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) | 88.04 Milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 26 |
| RN6G 15 mg/kg | Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) | 78.45 Milliliter per kilogram (mL/kg) | Geometric Coefficient of Variation 11 |