Lower Resp Tract Infection, Respiratory Syncytial Virus (RSV)
Conditions
Keywords
RV521, Pediatrics, Children, LRTI, Wheezing, Rhinitis, Cough, sisunatovir
Brief summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it. This study will be conducted in 3 parts: In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B. The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo. To participate in this study participants must meet the following criteria: 1. Age 1 month to 36 months 2. Weight ≥ 3.5 kg 3. Diagnosis of LRTI 4. Diagnosis of RSV 5. Hospitalization due to RSV LRTI
Detailed description
This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI. The clinical study consists of 3 parts, the third part (Part C) is optional: * Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 & 2) * Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 & 5) * Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI I The number of subjects enrolled in Parts A and B of the study will depend on the safety and PK data from the group of subjects enrolled in specified age cohorts and the subsequent recommendation of the Data Safety Monitoring Committee (DSMC). The DSMC may recommend a dose adjustment (either a reduction or an escalation) and/or regimen adjustment (Part B only) for subsequent subjects because of the observation of an unexpected safety/tolerability profile and/or differences between the observed and predicted exposure resulting from a specified dose of RV521.
Interventions
DRUGRV521
RV521 is an RSV F protein inhibitor administered orally
DRUGPlacebo
vehicle administered orally
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI. Due to the adaptive study design, the number of enrolled subjects may vary depending on the obtained PK and safety profiles. The clinical study consists of 3 parts: * Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 & 2) * Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 & 5) * Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI
Eligibility
Sex/Gender
ALL
Age
1 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥ 1 month and ≤ 36 months of age 2. Weight ≥ 3.5 kg 3. Clinical diagnosis of LRTI 4. A positive RSV diagnostic test 5. Hospitalised because of RSV LRTI 6. Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit 7. Expected to remain in hospital for a minimum of 3 days 8. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol
Exclusion criteria
1. Premature (gestational age less than 37 weeks) AND \<1 year of post-natal age 2. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug. 3. Any clinically significant ECG abnormalities. 4. Known to be immunocompromised. 5. High risk of having developing asthma. 6. Suspected of having a clinically significant bacterial infection. 7. History of renal failure. 8. Clinical evidence of hepatic decompensation 9. History of epilepsy or seizures, including febrile seizures 10. Allergy to test medication or constituents 11. Has received 1 or more doses of palivizumab at any time before Screening or received treatment with antiviral therapy for RSV (eg, ribavirin or intravenous \[IV\] immunoglobulin) within 3 months before the Screening Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | Anytime between 4 to 5 hours post-dose 6 (Day 3) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | Pre-dose 7 (Day 4) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 7= assessment prior to receiving dose 7 of IMP on Day 4. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | Pre-dose 8 (Day 4) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 8= assessment prior to receiving dose 8 of IMP on Day 4. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | Pre-dose 9 (Day 5) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 9= assessment prior to receiving dose 9 of IMP on Day 5. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | Pre-dose 10 (Day 5) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 10= assessment prior to receiving dose 10 of IMP on Day 5. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Hematology Results at Baseline | Baseline (pre-dose on Day 1) | Hematology parameters included basophils, eosinophils, mean cell hemoglobin concentration (MCHC), mean cell hemoglobin (MCH), mean cell volume (MCV), red blood cell count (RBC), hematocrit (HCT), hemoglobin (Hb), white blood cell count (WBC), lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used. |
| Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | At 48 hours post-dose on Day 1 | Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used. |
| Part B: Number of Participants With Abnormal Hematology Results at Baseline | Baseline (pre-dose on Day 1) | Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used. |
| Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used. |
| Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Baseline (pre-dose on Day 1) | Clinical chemistry parameters included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, protein, sodium and urea. Institutional laboratory normal ranges were used. |
| Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | At 48 hours post-dose on Day 1 | Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used. |
| Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Baseline (pre-dose on Day 1) | Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used. |
| Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used. |
| Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Baseline (pre-dose on Day 1) | Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per high power field \[hpf\]), erythrocytes (0 to 2 per hpf), granular casts (0 per low power field \[lpf\]), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8). |
| Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | At 48 hours post-dose on Day 1 | Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and potential of hydrogen (pH) (5 to 8). |
| Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Baseline (pre-dose on Day 1) | Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8). |
| Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8). |
| Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | Baseline (pre-dose on Day 1) | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QT interval corrected by Bazzett's formula (QTcB) interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | Anytime between 4 to 5 hours post-dose on Day 1 | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose | Anytime between 18 to 24 hours post-dose on Day 1 | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose | 48 hours post-dose on Day 1 | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | Baseline (pre-dose on Day 1) | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | Anytime between 4 to 5 hours post-dose 1 on Day 1 | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | Pre-dose 3 (Day 2) | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | Pre-dose 5 (Day 3) | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | Anytime between 4 to 5 hours post-dose 6 (Day 3) | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | Pre-dose 8 (Day 4) | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10 | Pre-dose 10 (Day 5) | A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | From start of IMP on Day 1 up to Day 7 | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event. |
| Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | From start of IMP on Day 1 up to Day 12 | An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event. |
| Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Baseline (pre-dose on Day 1) | Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Anytime between 18 to 24 hours post-dose on Day 1 | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | At 48 hours post-dose on Day 1 | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Baseline (pre-dose on Day 1) | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Anytime between 40 to 48 hours post-dose 10 on Day 5 | Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator. |
| Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline | Baseline (pre-dose on Day 1) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | Anytime between 4 to 5 hours post-dose on Day 1 | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose | At 12 hours post-dose on Day 1 | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose | Anytime between 18 to 24 hours post-dose on Day 1 | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose | 48 hours post-dose on Day 1 | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | Baseline (pre-dose on Day 1) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | Anytime between 4 to 5 hours post-dose 1 (Day 1) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | Pre-dose 2 (Day 1) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 2= assessment prior to receiving dose 2 of IMP on Day 1. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | Pre-dose 3 (Day 2) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 3= assessment prior to receiving dose 3 of IMP on Day 2. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | Pre-dose 4 (Day 2) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 4= assessment prior to receiving dose 4 of IMP on Day 2. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | Pre-dose 5 (Day 3) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 5= assessment prior to receiving dose 5 of IMP on Day 3. |
| Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | Pre-dose 6 (Day 3) | Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 6= assessment prior to receiving dose 6 of IMP on Day 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Time to Maximum Plasma Concentration (Tmax) | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part A: Maximum Observed Plasma Concentration (Cmax) | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population. |
| Part B: Maximum Observed Plasma Concentration (Cmax) | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1 | AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population. |
| Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population. |
| Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part A: Terminal Half-life (t1/2) | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part B: Terminal Half-life (t1/2) | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf) | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population. |
| Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf) | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part A: Trough Concentration at the End of First Dosing Interval (C12) | At 12 hours post-dose on Day 1 | — |
| Part B: Trough Concentration at the End of Dose 6 (C12) | At 12 hours post-dose 6 | — |
| Part A: Predicted Plasma Clearance | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population. |
| Part B: Predicted Plasma Clearance | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | Apparent volume of distribution was estimated as Dose/Kel\*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population. |
| Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | Apparent volume of distribution was estimated as Dose/Kel\*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part B: Accumulation Ratio | Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | Accumulation ratio was calculated as ratio of the area under the curve (AUC) during a single dosing interval under steady state conditions to the AUC during a dosing interval after one singe dose. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population. |
| Part B: Percentage Fluctuation | Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | Percentage fluctuation was calculated as 100\*(Cmax-Cmin)/Cavg, where Cmin=minimum plasma concentration and Cmax measured over dosing interval. |
| Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau) | Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | AUC(0 to tau) was determined using the linear trapezoidal method. |
| Part B: Average Plasma Concentration Over Dosing Interval (Cavg) | Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose) | Cavg was estimated as AUC(0 to tau)/tau, where tau=dosing interval (12 hours). |
| Part B: Minimum Observed Plasma Concentration | Day 3 Dose 6 (pre-dose) | — |
| Part B: Plasma Trough Concentration | Day 3 Dose 6 (pre-dose) | — |
| Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1 | Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects analysis of covariance (ANCOVA) model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group \>=1 month to \<6 months. |
| Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA) | Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1 | Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects ANCOVA model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group \>=1 month to \<6 months. |
| Part B: Time to Resolution of RSV-Related Signs and Symptoms | Up to Day 12 | Time to resolution was calculated for RSV-related signs and symptoms that were present at study start and was defined as the time of randomization to the time that RSV-related signs and symptoms were absent. |
| Part B: Time to Improvement in RSV-Related Signs and Symptoms | Up to Day 12 | Time to improvement was calculated for RSV-related signs and symptoms that were classified as moderate or severe during the course of the study and was defined as the time from randomization to the time that RSV-related signs and symptoms were mild or absent. |
| Part B: RSV Clinical Scoring System Scores | Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5 | RSV clinical score was a composite score for infants with RSV infection \>= 1 month of age based on 4 items (respiratory rate, wheezing, retraction of respiratory muscles and general condition). Score for each item ranged from 0 to 3 where 0=none/normal and 3=severe. Total score was calculated as sum of individual items and ranged from 0 to 12, where higher score indicated severe disease. RSV symptoms were graded as mild: score \<=5, moderate: score \> 5 but \< 9 and severe: score \>=9. |
| Part A: Time to Maximum Plasma Concentration (Tmax) | Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1 | No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the Pharmacokinetic (PK) population. |
Countries
Argentina, Canada, Chile, Costa Rica, Hungary, Israel, Malaysia, New Zealand, Panama, Poland, South Korea, Spain, Taiwan, Thailand, United Kingdom
Participant flow
Pre-assignment details
This study was planned to be conducted in 3 parts: Part A, B and optional part C. Part C was not conducted as part of a reassessment of the clinical development plan for RV521 (sisunatovir); hence, data is not reported for Part C in any section of the results. A total of 51 participants were enrolled in the study (Part A=19 and Part B=32).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: RV521 1.0 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 1.0 milligram per kilogram (mg/kg) of RV521 orally on Day 1. | 3 |
| Cohort 1: RV521 2.0 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.0 mg/kg of RV521 orally on Day 1. | 7 |
| Cohort 1: RV521 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received a single dose of 2.5 mg/kg of RV521 orally on Day 1. | 3 |
| Cohort 2: RV521 2.0 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received a single dose of 2 mg/kg of RV521 orally on Day 1. | 6 |
| Cohort 3: Placebo Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received placebo every 12 hours twice daily (BID) orally for 5 days. | 3 |
| Cohort 3: RSV1 2.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days. | 3 |
| Cohort 3: RV521 3.5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 3.5 mg/kg every 12 hours (BID) orally for 5 days. | 4 |
| Cohort 3: RV521 5 mg/kg Infants aged \>=6 months to \<=36 months hospitalized with RSV LRTI received RV521 5 mg/kg every 12 hours (BID) orally for 5 days. | 3 |
| Cohort 4: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days. | 1 |
| Cohort 4: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days. | 4 |
| Cohort 5: Placebo Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received placebo every 12 hours (BID) orally for 5 days. | 5 |
| Cohort 5: RV521 2.5 mg/kg Infants aged \>=1 month to \<6 months hospitalized with RSV LRTI received RV521 2.5 mg/kg every 12 hours (BID) orally for 5 days. | 8 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A (Screening Visit to Day 7) | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A (Screening Visit to Day 7) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A (Screening Visit to Day 7) | Parent/legal guardian request | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B (Screening Visit to Day 12) | Parent/legal guardian request | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: RV521 1.0 mg/kg | Cohort 1: RV521 2.0 mg/kg | Cohort 1: RV521 2.5 mg/kg | Cohort 2: RV521 2.0 mg/kg | Cohort 3: Placebo | Cohort 3: RSV1 2.5 mg/kg | Cohort 3: RV521 3.5 mg/kg | Cohort 3: RV521 5 mg/kg | Cohort 4: Placebo | Cohort 4: RV521 2.5 mg/kg | Cohort 5: Placebo | Cohort 5: RV521 2.5 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 28 days to 23 months | 1 Participants | 5 Participants | 3 Participants | 6 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants | 5 Participants | 8 Participants | 42 Participants |
| Age, Customized 2 to 11 years | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 7 Participants | 0 Participants | 5 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 7 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 7 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 0 Participants | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 4 Participants | 2 Participants | 6 Participants | 28 Participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 1 Participants | 5 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 5 Participants | 3 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 3 | 0 / 1 | 0 / 4 | 0 / 5 | 0 / 8 |
| other Total, other adverse events | 2 / 3 | 4 / 7 | 3 / 3 | 1 / 6 | 1 / 3 | 2 / 3 | 1 / 4 | 1 / 3 | 1 / 1 | 2 / 4 | 3 / 5 | 1 / 8 |
| serious Total, serious adverse events | 0 / 3 | 1 / 7 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 3 | 0 / 1 | 0 / 4 | 0 / 5 | 0 / 8 |
Outcome results
Primary
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose
Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
Time frame: At 48 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; above normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; above normal range | 3 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Potassium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Calcium; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | LDH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Chloride; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Bilirubin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Creatinine; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | GGT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Albumin; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Glucose; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Urea; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | ALP; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Protein; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | AST; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose | Sodium; above normal range | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
Clinical chemistry parameters included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 18 to 24 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 4 to 5 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: 48 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QT interval corrected by Bazzett's formula (QTcB) interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose
Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
Time frame: Anytime between 18 to 24 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | General appearance | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Respiratory | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | HEENT | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Neurological | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Respiratory | 4 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Neurological | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | HEENT | 2 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | General appearance | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | General appearance | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | HEENT | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Respiratory | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Neurological | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Neurological | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | HEENT | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | General appearance | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Respiratory | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose | Cardiovascular | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose
Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
Time frame: At 48 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | General appearance | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Respiratory | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | HEENT | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Neurological | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Respiratory | 3 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Neurological | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | HEENT | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | General appearance | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | General appearance | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | HEENT | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Respiratory | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Neurological | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Dermatologic | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Neurological | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Gastrointestinal | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | HEENT | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | General appearance | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Respiratory | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose | Cardiovascular | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General appearance | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 3 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 6 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 2 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General appearance | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General appearance | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General appearance | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 18 to 24 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 4 to 5 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: At 12 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: 48 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose
Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
Time frame: At 48 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; above normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; below normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Hb; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCHC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | HCT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Platelets; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Neutrophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCV; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | WBC; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Eosinophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Basophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | RBC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Lymphocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | Monocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose | MCH; below normal range | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Hematology Results at Baseline
Hematology parameters included basophils, eosinophils, mean cell hemoglobin concentration (MCHC), mean cell hemoglobin (MCH), mean cell volume (MCV), red blood cell count (RBC), hematocrit (HCT), hemoglobin (Hb), white blood cell count (WBC), lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 2 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose
Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and potential of hydrogen (pH) (5 to 8).
Time frame: At 48 hours post-dose on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Epithelial Cells; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | pH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Erythrocytes; above normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | pH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | pH; above normal range | 2 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Epithelial Cells; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Erythrocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | pH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Leukocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Leukocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Epithelial Cells; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | pH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Epithelial Cells; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Waxy cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | RBC cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | RBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | WBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | pH; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Waxy cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Granular casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Granular casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Erythrocytes; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Hyaline casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Hyaline casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | Erythrocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose | WBC cast; above normal range | 0 Participants |
Primary
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline
Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per high power field \[hpf\]), erythrocytes (0 to 2 per hpf), granular casts (0 per low power field \[lpf\]), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial Cells; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
Primary
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.
Time frame: From start of IMP on Day 1 up to Day 7
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 2 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 5 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 3 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10
Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
Time frame: Anytime between 40 to 48 hours post-dose 10 on Day 5
Population: Safety population included all participants who received at least 1 dose of IMP. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; above normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; above normal range | 1 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; above normal range | 5 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Chloride; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Creatinine; below normal range | 4 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Calcium; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Bilirubin; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | GGT; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | AST; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Glucose; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | LDH; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALP; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Potassium; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Protein; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Sodium; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | ALT; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Albumin; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10 | Urea; above normal range | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 3 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 2 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 1 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; below normal range | 3 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; below normal range | 4 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | LDH; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Chloride; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; below normal range | 2 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALP; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Calcium; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | AST; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Glucose; above normal range | 4 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Potassium; above normal range | 2 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Albumin; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Sodium; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Protein; below normal range | 2 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Bilirubin; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | GGT; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Urea; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | Creatinine; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline | ALT; above normal range | 3 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 40 to 48 hours post-dose 10 on Day 5
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 4 to 5 hours post-dose 1 on Day 1
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 4 to 5 hours post-dose 6 (Day 3)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Pre-dose 10 (Day 5)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Pre-dose 3 (Day 2)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Pre-dose 5 (Day 3)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Time frame: Pre-dose 8 (Day 4)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10
Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
Time frame: Anytime between 40 to 48 hours post-dose 10 on Day 5
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Cardiovascular | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | General appearance | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Neurological | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | HEENT | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Dermatologic | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Respiratory | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | General appearance | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | HEENT | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Respiratory | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Neurological | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Neurological | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | HEENT | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | General appearance | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Respiratory | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Cardiovascular | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | General appearance | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | HEENT | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Dermatologic | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Respiratory | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Gastrointestinal | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Neurological | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Neurological | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | General appearance | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Cardiovascular | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Dermatologic | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | HEENT | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Gastrointestinal | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Respiratory | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Neurological | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | General appearance | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | HEENT | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Respiratory | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Gastrointestinal | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Cardiovascular | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Dermatologic | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Cardiovascular | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Respiratory | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | HEENT | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Gastrointestinal | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | General appearance | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Neurological | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10 | Dermatologic | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 2 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 3 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 3 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 1 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 2 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 4 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Dermatologic | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | General Appearance | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Neurological | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Respiratory | 3 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Cardiovascular | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | Gastrointestinal | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline | HEENT | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 40 to 48 hours post-dose 10 on Day 5
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 4 to 5 hours post-dose 1 (Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: Anytime between 4 to 5 hours post-dose 6 (Day 3)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 10= assessment prior to receiving dose 10 of IMP on Day 5.
Time frame: Pre-dose 10 (Day 5)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 2= assessment prior to receiving dose 2 of IMP on Day 1.
Time frame: Pre-dose 2 (Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 3= assessment prior to receiving dose 3 of IMP on Day 2.
Time frame: Pre-dose 3 (Day 2)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 4= assessment prior to receiving dose 4 of IMP on Day 2.
Time frame: Pre-dose 4 (Day 2)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 5= assessment prior to receiving dose 5 of IMP on Day 3.
Time frame: Pre-dose 5 (Day 3)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 6= assessment prior to receiving dose 6 of IMP on Day 3.
Time frame: Pre-dose 6 (Day 3)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 7= assessment prior to receiving dose 7 of IMP on Day 4.
Time frame: Pre-dose 7 (Day 4)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 8= assessment prior to receiving dose 8 of IMP on Day 4.
Time frame: Pre-dose 8 (Day 4)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 9= assessment prior to receiving dose 9 of IMP on Day 5.
Time frame: Pre-dose 9 (Day 5)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9 | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10
Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
Time frame: Anytime between 40 to 48 hours post-dose 10 on Day 5
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; above normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; above normal range | 2 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; above normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; above normal range | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; above normal range | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; below normal range | 2 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; above normal range | 2 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCV; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Lymphocytes; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCH; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Hb; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | MCHC; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; above normal range | 6 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Platelets; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Eosinophils; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Basophils; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | HCT; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Monocytes; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | WBC; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | RBC; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10 | Neutrophils; below normal range | 1 Participants |
Primary
Part B: Number of Participants With Abnormal Hematology Results at Baseline
Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 2 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 2 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCV; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | HCT; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCH; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Neutrophils; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | WBC; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Hb; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Monocytes; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | RBC; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Basophils; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Platelets; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | MCHC; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Lymphocytes; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Hematology Results at Baseline | Eosinophils; below normal range | 2 Participants |
Primary
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10
Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).
Time frame: Anytime between 40 to 48 hours post-dose 10 on Day 5
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; above normal range | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; above normal range | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; above normal range | 2 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; above normal range | 1 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; above normal range | 2 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | pH; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | RBC cast; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Waxy cast; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | WBC cast; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Epithelial Cells; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Leukocytes; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Hyaline casts; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Granular casts; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10 | Erythrocytes; above normal range | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline
Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 1 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 1 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 2 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Hyaline casts; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | WBC cast; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Epithelial cells; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Erythrocytes; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Granular casts; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; below normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Leukocytes; above normal range | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | RBC cast; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; below normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | Waxy cast; above normal range | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Urinalysis Results at Baseline | pH; below normal range | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline
Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
Time frame: Baseline (pre-dose on Day 1)
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline | 0 Participants |
Primary
Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.
Time frame: From start of IMP on Day 1 up to Day 12
Population: Safety population included all participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 1 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 1: RV521 1.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 1: RV521 2.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 2 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 1 Participants |
| Cohort 1: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 1 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 2: RV521 2.0 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 1 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 1 Participants |
| Cohort 4: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 2 Participants |
| Cohort 4: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 3 Participants |
| Cohort 5: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs | 1 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | SAEs | 0 Participants |
| Cohort 5: RV521 2.5 mg/kg | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP | TEAEs leading to permanent discontinuation of IMP | 0 Participants |
Secondary
Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration
Apparent volume of distribution was estimated as Dose/Kel\*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate volume of distribution and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: RV521 2.0 mg/kg | Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration | 119 Litres per kilogram | Standard Deviation 87.4 |
Secondary
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | 23.1 Hours*nanogram per milliliter | — |
| Cohort 1: RV521 2.0 mg/kg | Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | 48.1 Hours*nanogram per milliliter | Standard Deviation 49.9 |
| Cohort 1: RV521 2.5 mg/kg | Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | 14 Hours*nanogram per milliliter | Standard Deviation 1.46 |
| Cohort 2: RV521 2.0 mg/kg | Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | 287 Hours*nanogram per milliliter | Standard Deviation 217 |
Secondary
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | 9.22 Hours*nanogram per milliliter | Standard Deviation 16 |
| Cohort 1: RV521 2.0 mg/kg | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | 45 Hours*nanogram per milliliter | Standard Deviation 48 |
| Cohort 1: RV521 2.5 mg/kg | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | 6.46 Hours*nanogram per milliliter | Standard Deviation 9.14 |
| Cohort 2: RV521 2.0 mg/kg | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | 201 Hours*nanogram per milliliter | Standard Deviation 143 |
Secondary
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate AUC(0 to inf) and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: RV521 2.0 mg/kg | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf) | 231 Hours*nanogram per milliliter | Standard Deviation 161 |
Secondary
Part A: Maximum Observed Plasma Concentration (Cmax)
No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Maximum Observed Plasma Concentration (Cmax) | 1.59 Nanograms per milliliter | Standard Deviation 2.76 |
| Cohort 1: RV521 2.0 mg/kg | Part A: Maximum Observed Plasma Concentration (Cmax) | 8.08 Nanograms per milliliter | Standard Deviation 7.94 |
| Cohort 1: RV521 2.5 mg/kg | Part A: Maximum Observed Plasma Concentration (Cmax) | 2.98 Nanograms per milliliter | Standard Deviation 3.09 |
| Cohort 2: RV521 2.0 mg/kg | Part A: Maximum Observed Plasma Concentration (Cmax) | 28 Nanograms per milliliter | Standard Deviation 17.5 |
Secondary
Part A: Predicted Plasma Clearance
Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 as at least 3 quantifiable concentrations were required to calculate clearance and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: RV521 2.0 mg/kg | Part A: Predicted Plasma Clearance | 12.7 Liters per hour per kilogram | Standard Deviation 7.66 |
Secondary
Part A: Terminal Half-life (t1/2)
T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed for Cohort 1 due to insufficient number of quantifiable sisunatovir concentrations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: RV521 2.0 mg/kg | Part A: Terminal Half-life (t1/2) | 6.22 Hours | Standard Deviation 1.46 |
Secondary
Part A: Time to Maximum Plasma Concentration (Tmax)
No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the Pharmacokinetic (PK) population.
Time frame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Population: Pharmacokinetic (PK) population included all participants who received IMP and had at least 1 post-dose PK concentration measurement.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Time to Maximum Plasma Concentration (Tmax) | 4.17 Hours | Full Range 4 |
| Cohort 1: RV521 2.0 mg/kg | Part A: Time to Maximum Plasma Concentration (Tmax) | 4.58 Hours | Full Range 4.42 |
| Cohort 1: RV521 2.5 mg/kg | Part A: Time to Maximum Plasma Concentration (Tmax) | 7 Hours | Full Range 4.87 |
| Cohort 2: RV521 2.0 mg/kg | Part A: Time to Maximum Plasma Concentration (Tmax) | 4.78 Hours | Full Range 2 |
Secondary
Part A: Trough Concentration at the End of First Dosing Interval (C12)
Time frame: At 12 hours post-dose on Day 1
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part A: Trough Concentration at the End of First Dosing Interval (C12) | NA Nanogram per milliliter | — |
| Cohort 1: RV521 2.0 mg/kg | Part A: Trough Concentration at the End of First Dosing Interval (C12) | 0.851 Nanogram per milliliter | Standard Deviation 1.52 |
| Cohort 1: RV521 2.5 mg/kg | Part A: Trough Concentration at the End of First Dosing Interval (C12) | 1.06 Nanogram per milliliter | — |
| Cohort 2: RV521 2.0 mg/kg | Part A: Trough Concentration at the End of First Dosing Interval (C12) | 10.4 Nanogram per milliliter | Standard Deviation 9.57 |
Secondary
Part B: Accumulation Ratio
Accumulation ratio was calculated as ratio of the area under the curve (AUC) during a single dosing interval under steady state conditions to the AUC during a dosing interval after one singe dose. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Accumulation ratio could not be calculated as it was depended on AUC which was not calculable due to insufficient number of quantifiable concentrations.
Secondary
Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration
Apparent volume of distribution was estimated as Dose/Kel\*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate volume of distribution and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.
Secondary
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 1 | 288 Hours*nanogram per milliliter | Standard Deviation 251 |
| Cohort 1: RV521 1.0 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 6 | 225 Hours*nanogram per milliliter | Standard Deviation 233 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 1 | 163 Hours*nanogram per milliliter | Standard Deviation 132 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 6 | 477 Hours*nanogram per milliliter | Standard Deviation 594 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 1 | 1170 Hours*nanogram per milliliter | Standard Deviation 1460 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 6 | 1560 Hours*nanogram per milliliter | Standard Deviation 1010 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 6 | 1310 Hours*nanogram per milliliter | Standard Deviation 802 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 1 | 342 Hours*nanogram per milliliter | Standard Deviation 240 |
| Cohort 4: Placebo | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 1 | 315 Hours*nanogram per milliliter | Standard Deviation 386 |
| Cohort 4: Placebo | Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t]) | Dose 6 | 1140 Hours*nanogram per milliliter | Standard Deviation 845 |
Secondary
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Dose 6 | 87.9 Hours*nanogram per milliliter | — |
| Cohort 1: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Dose 6 | 184 Hours*nanogram per milliliter | — |
| Cohort 1: RV521 2.5 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Dose 1 | 1170 Hours*nanogram per milliliter | Standard Deviation 1460 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Dose 1 | 127 Hours*nanogram per milliliter | — |
| Cohort 2: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Dose 6 | 1110 Hours*nanogram per milliliter | — |
| Cohort 4: Placebo | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Dose 1 | 160 Hours*nanogram per milliliter | Standard Deviation 120 |
| Cohort 4: Placebo | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12) | Dose 6 | 1600 Hours*nanogram per milliliter | — |
Secondary
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate AUC(0 to inf) and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.
Secondary
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau)
AUC(0 to tau) was determined using the linear trapezoidal method.
Time frame: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau) | 87.9 Hours*nanogram per milliliter |
| Cohort 1: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau) | 184 Hours*nanogram per milliliter |
| Cohort 2: RV521 2.0 mg/kg | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau) | 1110 Hours*nanogram per milliliter |
| Cohort 4: Placebo | Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau) | 1600 Hours*nanogram per milliliter |
Secondary
Part B: Average Plasma Concentration Over Dosing Interval (Cavg)
Cavg was estimated as AUC(0 to tau)/tau, where tau=dosing interval (12 hours).
Time frame: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Average Plasma Concentration Over Dosing Interval (Cavg) | 7.32 Nanogram per milliliter |
| Cohort 1: RV521 2.0 mg/kg | Part B: Average Plasma Concentration Over Dosing Interval (Cavg) | 15.3 Nanogram per milliliter |
| Cohort 2: RV521 2.0 mg/kg | Part B: Average Plasma Concentration Over Dosing Interval (Cavg) | 92.7 Nanogram per milliliter |
| Cohort 4: Placebo | Part B: Average Plasma Concentration Over Dosing Interval (Cavg) | 133 Nanogram per milliliter |
Secondary
Part B: Maximum Observed Plasma Concentration (Cmax)
No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 1 | 43.2 Nanograms per milliliter | Standard Deviation 36.7 |
| Cohort 1: RV521 1.0 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 6 | 30.9 Nanograms per milliliter | Standard Deviation 31.3 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 1 | 24.9 Nanograms per milliliter | Standard Deviation 20 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 6 | 67.8 Nanograms per milliliter | Standard Deviation 86.3 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 1 | 115 Nanograms per milliliter | Standard Deviation 182 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 6 | 212 Nanograms per milliliter | Standard Deviation 157 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 6 | 133 Nanograms per milliliter | Standard Deviation 64.8 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 1 | 39.3 Nanograms per milliliter | Standard Deviation 26.4 |
| Cohort 4: Placebo | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 1 | 56.5 Nanograms per milliliter | Standard Deviation 88.1 |
| Cohort 4: Placebo | Part B: Maximum Observed Plasma Concentration (Cmax) | Dose 6 | 177 Nanograms per milliliter | Standard Deviation 151 |
Secondary
Part B: Minimum Observed Plasma Concentration
Time frame: Day 3 Dose 6 (pre-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Minimum Observed Plasma Concentration | 8.51 Nanograms per milliliter | Standard Deviation 9.87 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Minimum Observed Plasma Concentration | 24.3 Nanograms per milliliter | Standard Deviation 24.7 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Minimum Observed Plasma Concentration | 70.8 Nanograms per milliliter | Standard Deviation 20.9 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Minimum Observed Plasma Concentration | 96.7 Nanograms per milliliter | Standard Deviation 48.6 |
| Cohort 4: Placebo | Part B: Minimum Observed Plasma Concentration | 59.6 Nanograms per milliliter | Standard Deviation 65.7 |
Secondary
Part B: Percentage Fluctuation
Percentage fluctuation was calculated as 100\*(Cmax-Cmin)/Cavg, where Cmin=minimum plasma concentration and Cmax measured over dosing interval.
Time frame: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Percentage Fluctuation | 132 Percentage of fluctuation |
| Cohort 1: RV521 2.0 mg/kg | Part B: Percentage Fluctuation | 123 Percentage of fluctuation |
| Cohort 2: RV521 2.0 mg/kg | Part B: Percentage Fluctuation | 8.63 Percentage of fluctuation |
| Cohort 4: Placebo | Part B: Percentage Fluctuation | 98.1 Percentage of fluctuation |
Secondary
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)
Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects ANCOVA model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group \>=1 month to \<6 months.
Time frame: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoints. Data for Cohorts 4 and 5 were combined as pre-specified in statistical analysis plan.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA) | 60 hours | -69.56 Percent change | Standard Error 46.32 |
| Cohort 1: RV521 1.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA) | 156 hours | -10.00 Percent change | Standard Error 51.88 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA) | 60 hours | -54.74 Percent change | Standard Error 34.87 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA) | 156 hours | -41.20 Percent change | Standard Error 34.01 |
Comparison: 60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.95% CI: [-91.68, 121.33]
Comparison: 156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.95% CI: [-143.96, 81.57]
Secondary
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects analysis of covariance (ANCOVA) model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group \>=1 month to \<6 months.
Time frame: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
Population: Modified Intent to Treat (mITT) population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoints. Data for Cohorts 4 and 5 were combined as pre-specified in statistical analysis plan.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | 60 hours | -23.27 Percent change | Standard Error 10.48 |
| Cohort 1: RV521 1.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | 156 hours | -32.31 Percent change | Standard Error 11.52 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | 60 hours | -31.29 Percent change | Standard Error 8.19 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | 156 hours | -47.53 Percent change | Standard Error 8.03 |
Comparison: 60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.95% CI: [-31.78, 15.74]
Comparison: 156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.95% CI: [-40.15, 9.7]Mixed effects analysis of covariance
Secondary
Part B: Plasma Trough Concentration
Time frame: Day 3 Dose 6 (pre-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Plasma Trough Concentration | 8.51 Nanograms per milliliter | Standard Deviation 9.87 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Plasma Trough Concentration | 24.3 Nanograms per milliliter | Standard Deviation 24.7 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Plasma Trough Concentration | 70.8 Nanograms per milliliter | Standard Deviation 20.9 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Plasma Trough Concentration | 96.7 Nanograms per milliliter | Standard Deviation 48.6 |
| Cohort 4: Placebo | Part B: Plasma Trough Concentration | 59.6 Nanograms per milliliter | Standard Deviation 65.7 |
Secondary
Part B: Predicted Plasma Clearance
Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate clearance and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.
Secondary
Part B: RSV Clinical Scoring System Scores
RSV clinical score was a composite score for infants with RSV infection \>= 1 month of age based on 4 items (respiratory rate, wheezing, retraction of respiratory muscles and general condition). Score for each item ranged from 0 to 3 where 0=none/normal and 3=severe. Total score was calculated as sum of individual items and ranged from 0 to 12, where higher score indicated severe disease. RSV symptoms were graded as mild: score \<=5, moderate: score \> 5 but \< 9 and severe: score \>=9.
Time frame: Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5
Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 0.7 Units on a scale | Standard Deviation 0.58 |
| Cohort 1: RV521 1.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 2.0 Units on a scale | Standard Deviation 1.73 |
| Cohort 1: RV521 1.0 mg/kg | Part B: RSV Clinical Scoring System Scores | 40 to 48 hours post-dose 10 | 0.3 Units on a scale | Standard Deviation 0.58 |
| Cohort 1: RV521 1.0 mg/kg | Part B: RSV Clinical Scoring System Scores | Baseline | 3.5 Units on a scale | Standard Deviation 2.12 |
| Cohort 1: RV521 1.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 1.0 Units on a scale | Standard Deviation 1 |
| Cohort 1: RV521 1.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 0.0 Units on a scale | — |
| Cohort 1: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | 40 to 48 hours post-dose 10 | 1.0 Units on a scale | Standard Deviation 1 |
| Cohort 1: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 4.0 Units on a scale | Standard Deviation 2.65 |
| Cohort 1: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | Baseline | 5.0 Units on a scale | Standard Deviation 1.73 |
| Cohort 1: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 3.0 Units on a scale | Standard Deviation 1.73 |
| Cohort 1: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 3.5 Units on a scale | Standard Deviation 2.12 |
| Cohort 1: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 2.7 Units on a scale | Standard Deviation 2.08 |
| Cohort 1: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | Baseline | 6.8 Units on a scale | Standard Deviation 2.5 |
| Cohort 1: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 1.3 Units on a scale | Standard Deviation 1.5 |
| Cohort 1: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | 40 to 48 hours post-dose 10 | 0.5 Units on a scale | Standard Deviation 0.58 |
| Cohort 1: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 1.8 Units on a scale | Standard Deviation 1.5 |
| Cohort 1: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 1.5 Units on a scale | Standard Deviation 0.71 |
| Cohort 1: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 2.5 Units on a scale | Standard Deviation 1.29 |
| Cohort 2: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | 40 to 48 hours post-dose 10 | 0.0 Units on a scale | Standard Deviation 0 |
| Cohort 2: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 2.5 Units on a scale | Standard Deviation 3.54 |
| Cohort 2: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 1.0 Units on a scale | Standard Deviation 1.41 |
| Cohort 2: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | Baseline | 4.5 Units on a scale | Standard Deviation 6.36 |
| Cohort 2: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 1.0 Units on a scale | — |
| Cohort 2: RV521 2.0 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 2.5 Units on a scale | Standard Deviation 3.54 |
| Cohort 4: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 1.0 Units on a scale | — |
| Cohort 4: Placebo | Part B: RSV Clinical Scoring System Scores | Baseline | 8.0 Units on a scale | — |
| Cohort 4: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 4.0 Units on a scale | — |
| Cohort 4: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 3.0 Units on a scale | — |
| Cohort 4: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 1.0 Units on a scale | — |
| Cohort 4: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 5.0 Units on a scale | Standard Deviation 0 |
| Cohort 4: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | Baseline | 6.8 Units on a scale | Standard Deviation 2.22 |
| Cohort 4: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 2.0 Units on a scale | Standard Deviation 1.41 |
| Cohort 4: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 1.3 Units on a scale | Standard Deviation 0.58 |
| Cohort 4: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | 40 to 48 hours post-dose 10 | 1.0 Units on a scale | Standard Deviation 1 |
| Cohort 4: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 3.3 Units on a scale | Standard Deviation 0.96 |
| Cohort 5: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 1.8 Units on a scale | Standard Deviation 0.5 |
| Cohort 5: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 1.6 Units on a scale | Standard Deviation 0.55 |
| Cohort 5: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 1.4 Units on a scale | Standard Deviation 1.14 |
| Cohort 5: Placebo | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 1.8 Units on a scale | Standard Deviation 1.1 |
| Cohort 5: Placebo | Part B: RSV Clinical Scoring System Scores | Baseline | 6.2 Units on a scale | Standard Deviation 3.56 |
| Cohort 5: Placebo | Part B: RSV Clinical Scoring System Scores | 40 to 48 hours post-dose 10 | 1.2 Units on a scale | Standard Deviation 1.1 |
| Cohort 5: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | Baseline | 6.0 Units on a scale | Standard Deviation 2.73 |
| Cohort 5: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | 40 to 48 hours post-dose 10 | 0.6 Units on a scale | Standard Deviation 0.52 |
| Cohort 5: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 5 | 3.9 Units on a scale | Standard Deviation 2.75 |
| Cohort 5: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 7 | 2.3 Units on a scale | Standard Deviation 2.12 |
| Cohort 5: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 9 | 2.3 Units on a scale | Standard Deviation 0.96 |
| Cohort 5: RV521 2.5 mg/kg | Part B: RSV Clinical Scoring System Scores | pre-dose 3 | 4.3 Units on a scale | Standard Deviation 2.38 |
Secondary
Part B: Terminal Half-life (t1/2)
T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies participants with evaluable data for this PK parameter. Analysis could not be performed as at least 3 quantifiable concentrations were required to calculate t1/2 and this criteria could not be fulfilled due to insufficient number of quantifiable concentrations.
Secondary
Part B: Time to Improvement in RSV-Related Signs and Symptoms
Time to improvement was calculated for RSV-related signs and symptoms that were classified as moderate or severe during the course of the study and was defined as the time from randomization to the time that RSV-related signs and symptoms were mild or absent.
Time frame: Up to Day 12
Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 2.25 Days | Full Range 1.5 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 0.50 Days | Full Range 0.5 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 3.15 Days | Full Range 2.1 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 2.55 Days | Full Range 1.1 |
| Cohort 4: Placebo | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 1.90 Days | Full Range 1.9 |
| Cohort 4: RV521 2.5 mg/kg | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 4.35 Days | Full Range 3.6 |
| Cohort 5: Placebo | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 3.00 Days | Full Range 1 |
| Cohort 5: RV521 2.5 mg/kg | Part B: Time to Improvement in RSV-Related Signs and Symptoms | 6.00 Days | Full Range 1.5 |
Secondary
Part B: Time to Maximum Plasma Concentration (Tmax)
No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Time frame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 1 | 4.6 Hours |
| Cohort 1: RV521 1.0 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 6 | 4.43 Hours |
| Cohort 1: RV521 2.0 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 1 | 4.32 Hours |
| Cohort 1: RV521 2.0 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 6 | 3.95 Hours |
| Cohort 1: RV521 2.5 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 1 | 4.17 Hours |
| Cohort 1: RV521 2.5 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 6 | 4.53 Hours |
| Cohort 2: RV521 2.0 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 6 | 4.58 Hours |
| Cohort 2: RV521 2.0 mg/kg | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 1 | 4.03 Hours |
| Cohort 4: Placebo | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 1 | 4.31 Hours |
| Cohort 4: Placebo | Part B: Time to Maximum Plasma Concentration (Tmax) | Dose 6 | 4.29 Hours |
Secondary
Part B: Time to Resolution of RSV-Related Signs and Symptoms
Time to resolution was calculated for RSV-related signs and symptoms that were present at study start and was defined as the time of randomization to the time that RSV-related signs and symptoms were absent.
Time frame: Up to Day 12
Population: mITT population included all participants who received at least 1 dose of IMP (RV521 or placebo) and had a pre-treatment positive RSV nasopharyngeal swab confirmed by the central laboratory and agreed by the project team during blind data review meeting. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 6.20 Days | Full Range 6.1 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 6.20 Days | Full Range 6.2 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 6.45 Days | Full Range 5.9 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 3.80 Days | Full Range 2.6 |
| Cohort 4: Placebo | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 4.90 Days | Full Range 4.9 |
| Cohort 4: RV521 2.5 mg/kg | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 6.30 Days | Full Range 4.6 |
| Cohort 5: Placebo | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 6.00 Days | Full Range 2.5 |
| Cohort 5: RV521 2.5 mg/kg | Part B: Time to Resolution of RSV-Related Signs and Symptoms | 6.10 Days | Full Range 4.1 |
Secondary
Part B: Trough Concentration at the End of Dose 6 (C12)
Time frame: At 12 hours post-dose 6
Population: PK population included all participants who received IMP and had at least 1 post-dose PK concentration measurement. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: RV521 1.0 mg/kg | Part B: Trough Concentration at the End of Dose 6 (C12) | 7.6 Nanograms per milliliter | Standard Deviation 8.33 |
| Cohort 1: RV521 2.0 mg/kg | Part B: Trough Concentration at the End of Dose 6 (C12) | 9.55 Nanograms per milliliter | Standard Deviation 9.75 |
| Cohort 1: RV521 2.5 mg/kg | Part B: Trough Concentration at the End of Dose 6 (C12) | 36.9 Nanograms per milliliter | Standard Deviation 5.3 |
| Cohort 2: RV521 2.0 mg/kg | Part B: Trough Concentration at the End of Dose 6 (C12) | 89.8 Nanograms per milliliter | Standard Deviation 99.1 |
| Cohort 4: Placebo | Part B: Trough Concentration at the End of Dose 6 (C12) | 124 Nanograms per milliliter | Standard Deviation 167 |