COVID-19
Conditions
Brief summary
LMN-301 is to prevent infection by severe acute respiratory syndrome-corona virus (SARS-CoV-2) (the virus causing coronavirus disease of 2019 (COVID-19) in uninfected individuals. This study aims to assess whether the formulation will cause irritation when administered in the nose, and how long its protective effects will last. Thirty five healthy adult volunteers will participate in this study.
Interventions
BIOLOGICALLMN-301
Intranasally administered powder.
Sponsors
Lumen Bioscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Individuals must meet all the following criteria to be eligible to participate in this study: 1. Adult (between 18 and 65 years of age) at screening 2. BMI ≥ 18.0 and ≤ 30.0 kg/m2, with a maximum body weight of 120 kg at screening. 3. General good health, without significant medical illness or abnormal physical examination findings per investigator discretion. 4. No clinically significant laboratory values at screening for haematology, serum chemistry, coagulation, and urinalysis in the opinion of the Investigator. A repeat test is allowed at the investigator's discretion. 5. Normal electrocardiogram (ECG) with no QTcF prolongation. 6. Must have provided written informed consent to participate in the clinical trial before any study-related activities are carried out and, in the Investigator's opinion, must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 7. In the investigator's opinion, participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions. Female volunteers: 1. Must be of non-child-bearing potential, i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause (confirmed with follicle stimulating hormone (FSH) testing), or 2. If of child-bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test before the first study drug administration. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use a highly effective method of contraception from signing consent, throughout the study and for at least 30 days after the last dose of study drug. For contraception guidelines see Appendix 4. 9\. Male volunteers must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom in addition to having the female partner use a highly effective contraceptive method (Appendix 4) from signing consent, during the study, and at least 90 days after the last dose of study drug.
Exclusion criteria
Individuals will be excluded from this study if they meet any of the following criteria: 1. History or presence of clinically significant disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease, including any acute illness or surgery within the past 3 months prior to screening determined by the PI to be clinically relevant. 2. Known allergy or previous anaphylaxis to any components of the investigational product 3. Allergies, history of allergic disease or chronic respiratory diseases including mild asthma. History of childhood asthma or childhood allergies are not exclusionary. 4. History of nasal or upper respiratory pathology or abnormalities 5. Ongoing, defined as within 30 days of dosing through end of follow-up, usage of nasal spray or nasal drops 6. Treatment with an experimental device or compound within 30 days of the first dose of study drug. 7. Treatment within 30 days of the first dose of the study medication or planned use within the study period with immunomodulator or immunosuppressant agent or medicines over-the-counter (OTC), herbal, prescription, or supplement) with significant activity in the respiratory tract. 8. Pregnancy, anticipated pregnancy, or breastfeeding/lactating 9. Alcohol or drug abuse/dependency (defined as more than 10 standard drinks per week or more than 4 standard drinks on any one day, where 1 standard drink is 10 g of pure alcohol) within 3 months prior to screening. 10. Positive urine toxicology screen for drugs of abuse. Repeat testing is allowed at investigator discretion. Tobacco or nicotine consumption is not permitted from screening and until the end of follow-up. 11. Positive alcohol breath test. Repeat test is allowed at investigator discretion. 12. Individuals unable or unwilling to provide adequate informed consent 13. COVID-19 positive 14. Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Daily for 28 days | All adverse events (AEs) will be coded using the latest version of MedDRA by system organ class (SOC) and preferred term, classified from verbatim terms. The number of treatment-emergent AEs (TEAEs) as well as the number and percentage of participants with at least one TEAE, will be summarized by SOC and preferred term. Summaries of TEAEs by severity as assessed by CTCAE v5.0 and relationship will also be presented. Summaries will also be presented for serious adverse events (SAEs), TEAEs leading to death or study withdrawal. The duration of all AEs will be determined and included in the listings. Solicited and unsolicited TEAEs will be summarized separately. |
| Number of Participants Discontinuing From the Study | For 28 days after the first dose of LMN-301 | The endpoint is the number of participants discontinuing from the study. |
| Changes From Baseline of Systolic and Diastolic Blood Pressure. | In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28. | Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics. |
| Changes From Baseline of Pulse Rate. | In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28. | Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics. |
| Changes From Baseline of Oral Temperature. | In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28. | Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics. |
| Changes From Baseline of Hemoglobin. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like hemoglobin. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Changes From Baseline of Respiratory Rate. | In part A respiratory rate is measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28. | Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics. |
| Changes From Baseline of Hematocrit. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures such as hematocrit. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Platelets (10^9/L) | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures such as platelets. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Neutrophils. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like neutrophils. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline of Alkaline Phosphatase. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures such as alkaline phosphatase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Alanine Transaminase. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like alanine transaminase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Asparate Aminotransferase. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like asparate aminotransferase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Urea. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like urea. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Creatinine. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like creatinine. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Gamma Glutamyl Transferase. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like gamma glutamyl transferase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Bilirubin. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like bilirubin. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline in Lactate Dehydrogenase. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like lactate dehydrogenase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Change From Baseline of Prothrombin Intl. Normalized Ratio. | For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28 | Clinical laboratory safety data will be summarized by laboratory measures like prothrombin intl. normalized ratio. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant. |
| Changes From Baseline of Single RR Heart Rate (Beats/Min). | Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B). | The following ECG parameters will be analyzed: single RR heart rate (beats/min). Observed values and changes from baseline for single RR heart rate (beats/min). will be summarized at each scheduled timepoint using descriptive statistics. |
| Changes From Baseline of QRS Duration, Single Beat (ms). | Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B). | The following ECG parameters will be analyzed: QRS duration, single beat (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics. |
| Change From Baseline in PR Interval, Single Beat (ms). | Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B). | The following ECG parameters will be analyzed: PR interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics. |
| Change From Baseline in QTcB Interval, Single-beat (ms) | Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B). | The following ECG parameters will be analyzed: QTcB Interval. Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics. |
| Change From Baseline in QTcF Interval (ms). | Change from baseline to end of study. | The following ECG parameters will be analyzed: QTcF Interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics. For QTcF Interval, the number of participants with values greater than 450 (and 480, 500) msec or an increase from baseline of at least 30 (and 60) msec will also be tabulated, in accordance with International Conference of Harmonization (ICH) E14 |
| Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28 | The sino-nasal outcome test (SNOT-22) is to measure the consequences of rhinosinusitis. Scores will be totaled for all 22 items. The minimum score on the sinonasal outcome test-22 (SNOT-22) is 0 and the maximum score is 110. Changes from baseline in individual total sinonasal outcome test-22 (SNOT-22) scores will be calculated as the post-baseline value minus the baseline value. Thus, a negative change will reflect an improvement in the corresponding score. Observed values and changes from baseline will be summarized at each scheduled timepoint by treatment using descriptive statistics and tabulated for each cohort (dose level) and overall. Individual symptoms will be listed, with the 5 most important issues flagged. The total SNOT score will also be included in the listing. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sentinel Cohort Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril) | 5 |
| Main Cohort Group 1 Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total) | 10 |
| Main Cohort Group 2 Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total) | 10 |
| Main Cohort Group 3 Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total) | 10 |
| Total | 35 |
Baseline characteristics
| Characteristic | Total | Sentinel Cohort | Main Cohort Group 1 | Main Cohort Group 2 | Main Cohort Group 3 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 5 Participants | 10 Participants | 10 Participants | 10 Participants |
| Age, Continuous | 37.4 years STANDARD_DEVIATION 14.86 | 29.4 years STANDARD_DEVIATION 15.66 | 40.6 years STANDARD_DEVIATION 16.32 | 37.9 years STANDARD_DEVIATION 14.63 | 33.8 years STANDARD_DEVIATION 14.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 5 Participants | 9 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 3 Participants | 6 Participants | 8 Participants | 5 Participants |
| Region of Enrollment Australia | 35 participants | 5 participants | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 15 Participants | 3 Participants | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 20 Participants | 2 Participants | 6 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 5 / 5 | 9 / 10 | 10 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 5 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Alanine Transaminase.
Clinical laboratory safety data will be summarized by laboratory measures like alanine transaminase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 8 | -2.0 Alanine Transaminase (U/L) | Standard Deviation 2.24 |
| Sentinel Cohort | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 14 | 0.2 Alanine Transaminase (U/L) | Standard Deviation 2.24 |
| Sentinel Cohort | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 2 | -0.4 Alanine Transaminase (U/L) | Standard Deviation 2.3 |
| Main Cohort Group 1 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 3 | 0 Alanine Transaminase (U/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 7 | 0.8 Alanine Transaminase (U/L) | Standard Deviation 8.18 |
| Main Cohort Group 1 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 14 | -0.7 Alanine Transaminase (U/L) | Standard Deviation 9.29 |
| Main Cohort Group 1 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 28 | -0.8 Alanine Transaminase (U/L) | Standard Deviation 3.79 |
| Main Cohort Group 1 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 4 | -2.6 Alanine Transaminase (U/L) | Standard Deviation 3.06 |
| Main Cohort Group 2 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 4 | 0 Alanine Transaminase (U/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 7 | 2.1 Alanine Transaminase (U/L) | Standard Deviation 5.88 |
| Main Cohort Group 2 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 14 | 1.2 Alanine Transaminase (U/L) | Standard Deviation 7.68 |
| Main Cohort Group 2 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 28 | 3.7 Alanine Transaminase (U/L) | Standard Deviation 11.37 |
| Main Cohort Group 2 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 3 | -0.9 Alanine Transaminase (U/L) | Standard Deviation 2.13 |
| Main Cohort Group 3 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 14 | -2.9 Alanine Transaminase (U/L) | Standard Deviation 4.43 |
| Main Cohort Group 3 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 7 | -2.8 Alanine Transaminase (U/L) | Standard Deviation 4.61 |
| Main Cohort Group 3 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 4 | 0 Alanine Transaminase (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 3 | -0.8 Alanine Transaminase (U/L) | Standard Deviation 2.39 |
| Main Cohort Group 3 | Change From Baseline in Alanine Transaminase. | Change from baseline in alanine transaminase (U/L) Day 28 | 3.7 Alanine Transaminase (U/L) | Standard Deviation 8.9 |
Primary
Change From Baseline in Asparate Aminotransferase.
Clinical laboratory safety data will be summarized by laboratory measures like asparate aminotransferase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 14 | -0.4 Asparate aminotransferase (U/L) | Standard Deviation 3.91 |
| Sentinel Cohort | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 8 | -1.0 Asparate aminotransferase (U/L) | Standard Deviation 4.3 |
| Sentinel Cohort | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 2 | -1.0 Asparate aminotransferase (U/L) | Standard Deviation 5.24 |
| Main Cohort Group 1 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 28 | 1.2 Asparate aminotransferase (U/L) | Standard Deviation 8.4 |
| Main Cohort Group 1 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 4 | -2.1 Asparate aminotransferase (U/L) | Standard Deviation 1.85 |
| Main Cohort Group 1 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 7 | 0.4 Asparate aminotransferase (U/L) | Standard Deviation 5.5 |
| Main Cohort Group 1 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 3 | 0 Asparate aminotransferase (U/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 14 | 0.6 Asparate aminotransferase (U/L) | Standard Deviation 6.95 |
| Main Cohort Group 2 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 3 | -0.8 Asparate aminotransferase (U/L) | Standard Deviation 3.26 |
| Main Cohort Group 2 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 28 | 4.7 Asparate aminotransferase (U/L) | Standard Deviation 16.73 |
| Main Cohort Group 2 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 4 | 0 Asparate aminotransferase (U/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 14 | -3.7 Asparate aminotransferase (U/L) | Standard Deviation 5.02 |
| Main Cohort Group 2 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 7 | -2.2 Asparate aminotransferase (U/L) | Standard Deviation 3.67 |
| Main Cohort Group 3 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 28 | -0.1 Asparate aminotransferase (U/L) | Standard Deviation 3.96 |
| Main Cohort Group 3 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 3 | -1.6 Asparate aminotransferase (U/L) | Standard Deviation 2.5 |
| Main Cohort Group 3 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 4 | 0 Asparate aminotransferase (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 7 | -2.9 Asparate aminotransferase (U/L) | Standard Deviation 5.99 |
| Main Cohort Group 3 | Change From Baseline in Asparate Aminotransferase. | Change from baseline in asparate aminotransferase (U/L) Day 14 | -1.4 Asparate aminotransferase (U/L) | Standard Deviation 4.4 |
Primary
Change From Baseline in Bilirubin.
Clinical laboratory safety data will be summarized by laboratory measures like bilirubin. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 2 | -1.0 Bilirubin (U/L) | Standard Deviation 3.16 |
| Sentinel Cohort | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 8 | -0.4 Bilirubin (U/L) | Standard Deviation 3.51 |
| Sentinel Cohort | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 14 | -3.4 Bilirubin (U/L) | Standard Deviation 3.21 |
| Main Cohort Group 1 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 7 | 0.6 Bilirubin (U/L) | Standard Deviation 4.07 |
| Main Cohort Group 1 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 4 | 1.2 Bilirubin (U/L) | Standard Deviation 1.87 |
| Main Cohort Group 1 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 14 | -0.1 Bilirubin (U/L) | Standard Deviation 3.6 |
| Main Cohort Group 1 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 28 | 1.9 Bilirubin (U/L) | Standard Deviation 3.6 |
| Main Cohort Group 1 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 3 | 0 Bilirubin (U/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 7 | -1.2 Bilirubin (U/L) | Standard Deviation 4.15 |
| Main Cohort Group 2 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 3 | 1.9 Bilirubin (U/L) | Standard Deviation 2.92 |
| Main Cohort Group 2 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 14 | -3.1 Bilirubin (U/L) | Standard Deviation 2.32 |
| Main Cohort Group 2 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 28 | -1.9 Bilirubin (U/L) | Standard Deviation 2.8 |
| Main Cohort Group 2 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 4 | 0 Bilirubin (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 3 | -0.5 Bilirubin (U/L) | Standard Deviation 2.42 |
| Main Cohort Group 3 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 14 | -0.1 Bilirubin (U/L) | Standard Deviation 3.7 |
| Main Cohort Group 3 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 28 | -0.7 Bilirubin (U/L) | Standard Deviation 3.83 |
| Main Cohort Group 3 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 4 | 0 Bilirubin (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Bilirubin. | Change from baseline in bilirubin (U/L) Day 7 | 2.1 Bilirubin (U/L) | Standard Deviation 2.88 |
Primary
Change From Baseline in Creatinine.
Clinical laboratory safety data will be summarized by laboratory measures like creatinine. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 14 | -2.4 Creatinine (umol/L) | Standard Deviation 7.54 |
| Sentinel Cohort | Change From Baseline in Creatinine. | Change from baseline in Creatinine (umol/L) Day 8 | 1.4 Creatinine (umol/L) | Standard Deviation 3.78 |
| Sentinel Cohort | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 2 | -2.8 Creatinine (umol/L) | Standard Deviation 3.03 |
| Main Cohort Group 1 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 28 | 3.5 Creatinine (umol/L) | Standard Deviation 7.37 |
| Main Cohort Group 1 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 4 | -0.5 Creatinine (umol/L) | Standard Deviation 7.01 |
| Main Cohort Group 1 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 7 | 0.7 Creatinine (umol/L) | Standard Deviation 6.71 |
| Main Cohort Group 1 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 3 | 0 Creatinine (umol/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 14 | -1.3 Creatinine (umol/L) | Standard Deviation 4.55 |
| Main Cohort Group 2 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 3 | 0.8 Creatinine (umol/L) | Standard Deviation 4.73 |
| Main Cohort Group 2 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 28 | -4.4 Creatinine (umol/L) | Standard Deviation 6.46 |
| Main Cohort Group 2 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 4 | 0 Creatinine (umol/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 14 | -4.3 Creatinine (umol/L) | Standard Deviation 5.81 |
| Main Cohort Group 2 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 7 | -1.4 Creatinine (umol/L) | Standard Deviation 6.42 |
| Main Cohort Group 3 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 28 | -1.7 Creatinine (umol/L) | Standard Deviation 6.63 |
| Main Cohort Group 3 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 3 | 1.0 Creatinine (umol/L) | Standard Deviation 2.94 |
| Main Cohort Group 3 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 4 | 0 Creatinine (umol/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 7 | -1.7 Creatinine (umol/L) | Standard Deviation 3.95 |
| Main Cohort Group 3 | Change From Baseline in Creatinine. | Change from baseline in creatinine (umol/L) Day 14 | 1.6 Creatinine (umol/L) | Standard Deviation 4.35 |
Primary
Change From Baseline in Gamma Glutamyl Transferase.
Clinical laboratory safety data will be summarized by laboratory measures like gamma glutamyl transferase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 14 | 0.2 Gamma Glutamyl Transferase (U/L) | Standard Deviation 1.48 |
| Sentinel Cohort | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 8 | -1.0 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.55 |
| Sentinel Cohort | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 2 | -0.6 Gamma Glutamyl Transferase (U/L) | Standard Deviation 3.78 |
| Main Cohort Group 1 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 28 | -1.0 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.62 |
| Main Cohort Group 1 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 7 | -0.7 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.78 |
| Main Cohort Group 1 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 14 | -0.3 Gamma Glutamyl Transferase (U/L) | Standard Deviation 3.47 |
| Main Cohort Group 1 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 4 | -0.6 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.91 |
| Main Cohort Group 1 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 3 | 0 Gamma Glutamyl Transferase (U/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 7 | -0.1 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.32 |
| Main Cohort Group 2 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 3 | -1.1 Gamma Glutamyl Transferase (U/L) | Standard Deviation 1.97 |
| Main Cohort Group 2 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 4 | 0 Gamma Glutamyl Transferase (U/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 14 | 1.0 Gamma Glutamyl Transferase (U/L) | Standard Deviation 3.67 |
| Main Cohort Group 2 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 28 | 2.2 Gamma Glutamyl Transferase (U/L) | Standard Deviation 3.8 |
| Main Cohort Group 3 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 4 | 0 Gamma Glutamyl Transferase (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 14 | 0.4 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.59 |
| Main Cohort Group 3 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 3 | -0.1 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.08 |
| Main Cohort Group 3 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 28 | 0.6 Gamma Glutamyl Transferase (U/L) | Standard Deviation 3.1 |
| Main Cohort Group 3 | Change From Baseline in Gamma Glutamyl Transferase. | Change from baseline in gamma glutamyl transferase (U/L) Day 7 | 1.0 Gamma Glutamyl Transferase (U/L) | Standard Deviation 2.45 |
Primary
Change From Baseline in Lactate Dehydrogenase.
Clinical laboratory safety data will be summarized by laboratory measures like lactate dehydrogenase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 2 | -0.8 Lactate Dehydrogenase (U/L) | Standard Deviation 58.13 |
| Sentinel Cohort | Change From Baseline in Lactate Dehydrogenase. | from baseline in Lactate Dehydrogenase (U/L) Day 8 | -14.4 Lactate Dehydrogenase (U/L) | Standard Deviation 53.58 |
| Sentinel Cohort | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 14 | -11.4 Lactate Dehydrogenase (U/L) | Standard Deviation 65.22 |
| Main Cohort Group 1 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 7 | -11.7 Lactate Dehydrogenase (U/L) | Standard Deviation 32.39 |
| Main Cohort Group 1 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 28 | -12.9 Lactate Dehydrogenase (U/L) | Standard Deviation 41.15 |
| Main Cohort Group 1 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 3 | 0 Lactate Dehydrogenase (U/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 4 | -12.3 Lactate Dehydrogenase (U/L) | Standard Deviation 26.24 |
| Main Cohort Group 1 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 14 | -7.5 Lactate Dehydrogenase (U/L) | Standard Deviation 43.48 |
| Main Cohort Group 2 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 7 | -25.7 Lactate Dehydrogenase (U/L) | Standard Deviation 20.32 |
| Main Cohort Group 2 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 14 | -27.6 Lactate Dehydrogenase (U/L) | Standard Deviation 22.39 |
| Main Cohort Group 2 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 28 | -16.4 Lactate Dehydrogenase (U/L) | Standard Deviation 23.01 |
| Main Cohort Group 2 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 3 | -7.4 Lactate Dehydrogenase (U/L) | Standard Deviation 15.04 |
| Main Cohort Group 2 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 4 | 0 Lactate Dehydrogenase (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 4 | 0 Lactate Dehydrogenase (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 3 | -13.2 Lactate Dehydrogenase (U/L) | Standard Deviation 14.8 |
| Main Cohort Group 3 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 7 | -9.8 Lactate Dehydrogenase (U/L) | Standard Deviation 21.44 |
| Main Cohort Group 3 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 28 | -12.0 Lactate Dehydrogenase (U/L) | Standard Deviation 19.2 |
| Main Cohort Group 3 | Change From Baseline in Lactate Dehydrogenase. | Change from baseline in Lactate Dehydrogenase (U/L) Day 14 | -3.7 Lactate Dehydrogenase (U/L) | Standard Deviation 23.76 |
Primary
Change From Baseline in Neutrophils.
Clinical laboratory safety data will be summarized by laboratory measures like neutrophils. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 8 | -0.18 Neutrophils (10^9 cells/L) | Standard Deviation 0.536 |
| Sentinel Cohort | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 14 | -0.38 Neutrophils (10^9 cells/L) | Standard Deviation 0.838 |
| Sentinel Cohort | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 2 | 0.56 Neutrophils (10^9 cells/L) | Standard Deviation 0.847 |
| Main Cohort Group 1 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 7 | 0.36 Neutrophils (10^9 cells/L) | Standard Deviation 0.664 |
| Main Cohort Group 1 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 2 | 0 Neutrophils (10^9 cells/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 3 | 0 Neutrophils (10^9 cells/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 4 | 0.2 Neutrophils (10^9 cells/L) | Standard Deviation 0.555 |
| Main Cohort Group 1 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 14 | 0.27 Neutrophils (10^9 cells/L) | Standard Deviation 1.19 |
| Main Cohort Group 1 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 28 | 0.12 Neutrophils (10^9 cells/L) | Standard Deviation 0.653 |
| Main Cohort Group 2 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 4 | 0 Neutrophils (10^9 cells/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 3 | -0.33 Neutrophils (10^9 cells/L) | Standard Deviation 0.602 |
| Main Cohort Group 2 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 7 | -0.34 Neutrophils (10^9 cells/L) | Standard Deviation 1.181 |
| Main Cohort Group 2 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 2 | -0.33 Neutrophils (10^9 cells/L) | Standard Deviation 0.602 |
| Main Cohort Group 2 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 28 | -0.62 Neutrophils (10^9 cells/L) | Standard Deviation 1.174 |
| Main Cohort Group 2 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 14 | -0.56 Neutrophils (10^9 cells/L) | Standard Deviation 0.932 |
| Main Cohort Group 3 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 28 | 0.24 Neutrophils (10^9 cells/L) | Standard Deviation 0.855 |
| Main Cohort Group 3 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 4 | 0 Neutrophils (10^9 cells/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 14 | 0.13 Neutrophils (10^9 cells/L) | Standard Deviation 0.538 |
| Main Cohort Group 3 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 7 | 2.06 Neutrophils (10^9 cells/L) | Standard Deviation 1.465 |
| Main Cohort Group 3 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 2 | 0.43 Neutrophils (10^9 cells/L) | Standard Deviation 0.817 |
| Main Cohort Group 3 | Change From Baseline in Neutrophils. | Change from baseline in neutrophils (10^9/L) Day 3 | 0.43 Neutrophils (10^9 cells/L) | Standard Deviation 0.817 |
Primary
Change From Baseline in Platelets (10^9/L)
Clinical laboratory safety data will be summarized by laboratory measures such as platelets. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 14 | -2.4 Platelets (10^9 cells/L) | Standard Deviation 27.65 |
| Sentinel Cohort | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 8 | 8.4 Platelets (10^9 cells/L) | Standard Deviation 16.64 |
| Sentinel Cohort | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 2 | 2.0 Platelets (10^9 cells/L) | Standard Deviation 18.07 |
| Main Cohort Group 1 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 28 | 1.8 Platelets (10^9 cells/L) | Standard Deviation 34.3 |
| Main Cohort Group 1 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 4 | -4.4 Platelets (10^9 cells/L) | Standard Deviation 12.67 |
| Main Cohort Group 1 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 7 | 0.9 Platelets (10^9 cells/L) | Standard Deviation 22.77 |
| Main Cohort Group 1 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 3 | 0 Platelets (10^9 cells/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 14 | 15.9 Platelets (10^9 cells/L) | Standard Deviation 30.55 |
| Main Cohort Group 2 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 3 | -5.4 Platelets (10^9 cells/L) | Standard Deviation 18.87 |
| Main Cohort Group 2 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 28 | -11.2 Platelets (10^9 cells/L) | Standard Deviation 12.56 |
| Main Cohort Group 2 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 4 | 0 Platelets (10^9 cells/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 14 | 12.3 Platelets (10^9 cells/L) | Standard Deviation 25.74 |
| Main Cohort Group 2 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 7 | -12.6 Platelets (10^9 cells/L) | Standard Deviation 10.86 |
| Main Cohort Group 3 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 28 | 12.0 Platelets (10^9 cells/L) | Standard Deviation 39.31 |
| Main Cohort Group 3 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 3 | -7.3 Platelets (10^9 cells/L) | Standard Deviation 7.84 |
| Main Cohort Group 3 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 4 | 0 Platelets (10^9 cells/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 7 | -9.2 Platelets (10^9 cells/L) | Standard Deviation 11.52 |
| Main Cohort Group 3 | Change From Baseline in Platelets (10^9/L) | Change from baseline in platelets (10^9/L) Day 14 | 21.2 Platelets (10^9 cells/L) | Standard Deviation 24.68 |
Primary
Change From Baseline in PR Interval, Single Beat (ms).
The following ECG parameters will be analyzed: PR interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).
Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in PR Interval, Single Beat (ms). | Change from baseline in PR Interval, single beat (ms) Day 14 | -4.94 PR Interval, single beat (ms) | Standard Deviation 12.88 |
| Main Cohort Group 1 | Change From Baseline in PR Interval, Single Beat (ms). | Change from baseline in PR Interval, single beat (ms) Day 28 | -0.51 PR Interval, single beat (ms) | Standard Deviation 6.87 |
| Main Cohort Group 2 | Change From Baseline in PR Interval, Single Beat (ms). | Change from baseline in PR Interval, single beat (ms) Day 28 | 1.06 PR Interval, single beat (ms) | Standard Deviation 3.96 |
| Main Cohort Group 3 | Change From Baseline in PR Interval, Single Beat (ms). | Change from baseline in PR Interval, single beat (ms) Day 28 | -1.53 PR Interval, single beat (ms) | Standard Deviation 11.38 |
Primary
Change From Baseline in QTcB Interval, Single-beat (ms)
The following ECG parameters will be analyzed: QTcB Interval. Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).
Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in QTcB Interval, Single-beat (ms) | Change from baseline in QTcB Interval, Single-beat (ms) Day 14 | 0.78 QTcB Interval, Single-beat (ms) | Standard Deviation 21.29 |
| Main Cohort Group 1 | Change From Baseline in QTcB Interval, Single-beat (ms) | Change from baseline in QTcB Interval, Single-beat (ms) Day 28 | 4.08 QTcB Interval, Single-beat (ms) | Standard Deviation 13.04 |
| Main Cohort Group 2 | Change From Baseline in QTcB Interval, Single-beat (ms) | Change from baseline in QTcB Interval, Single-beat (ms) Day 28 | -2.38 QTcB Interval, Single-beat (ms) | Standard Deviation 13.38 |
| Main Cohort Group 3 | Change From Baseline in QTcB Interval, Single-beat (ms) | Change from baseline in QTcB Interval, Single-beat (ms) Day 28 | -1.44 QTcB Interval, Single-beat (ms) | Standard Deviation 15.58 |
Primary
Change From Baseline in QTcF Interval (ms).
The following ECG parameters will be analyzed: QTcF Interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics. For QTcF Interval, the number of participants with values greater than 450 (and 480, 500) msec or an increase from baseline of at least 30 (and 60) msec will also be tabulated, in accordance with International Conference of Harmonization (ICH) E14
Time frame: Change from baseline to end of study.
Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in QTcF Interval (ms). | Change from baseline in QTcF Interval (ms) Day 14 | -4.54 QTcF Interval (ms) | Standard Deviation 17.81 |
| Main Cohort Group 1 | Change From Baseline in QTcF Interval (ms). | Change from baseline in QTcF Interval (ms) Day 28 | 0.92 QTcF Interval (ms) | Standard Deviation 8.73 |
| Main Cohort Group 2 | Change From Baseline in QTcF Interval (ms). | Change from baseline in QTcF Interval (ms) Day 28 | -2.91 QTcF Interval (ms) | Standard Deviation 14.32 |
| Main Cohort Group 3 | Change From Baseline in QTcF Interval (ms). | Change from baseline in QTcF Interval (ms) Day 28 | -3.47 QTcF Interval (ms) | Standard Deviation 11.68 |
Primary
Change From Baseline in Urea.
Clinical laboratory safety data will be summarized by laboratory measures like urea. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 8 | 0.24 Urea (U/L) | Standard Deviation 1.097 |
| Sentinel Cohort | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 14 | -0.86 Urea (U/L) | Standard Deviation 1.167 |
| Sentinel Cohort | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 2 | -0.42 Urea (U/L) | Standard Deviation 0.74 |
| Main Cohort Group 1 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 3 | 0 Urea (U/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 7 | 0.22 Urea (U/L) | Standard Deviation 1.018 |
| Main Cohort Group 1 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 14 | -0.28 Urea (U/L) | Standard Deviation 0.84 |
| Main Cohort Group 1 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 4 | -0.27 Urea (U/L) | Standard Deviation 1.036 |
| Main Cohort Group 1 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 28 | 0.28 Urea (U/L) | Standard Deviation 1.272 |
| Main Cohort Group 2 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 7 | -0.54 Urea (U/L) | Standard Deviation 1.179 |
| Main Cohort Group 2 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 3 | -0.25 Urea (U/L) | Standard Deviation 0.92 |
| Main Cohort Group 2 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 4 | 0 Urea (U/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 28 | -0.20 Urea (U/L) | Standard Deviation 1.247 |
| Main Cohort Group 2 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 14 | -0.38 Urea (U/L) | Standard Deviation 1.232 |
| Main Cohort Group 3 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 28 | -0.80 Urea (U/L) | Standard Deviation 1.103 |
| Main Cohort Group 3 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 3 | -0.71 Urea (U/L) | Standard Deviation 1.746 |
| Main Cohort Group 3 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 4 | 0 Urea (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 7 | -0.94 Urea (U/L) | Standard Deviation 0.84 |
| Main Cohort Group 3 | Change From Baseline in Urea. | Change from baseline in urea (U/L) Day 14 | -0.56 Urea (U/L) | Standard Deviation 1.106 |
Primary
Change From Baseline of Alkaline Phosphatase.
Clinical laboratory safety data will be summarized by laboratory measures such as alkaline phosphatase. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline of Alkaline Phosphatase. | Change from baseline in Alkaline Phosphatase (U/L) Day 14 | -1.8 Alkaline Phosphatase (U/L) | Standard Deviation 7.29 |
| Sentinel Cohort | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 8 | 1.8 Alkaline Phosphatase (U/L) | Standard Deviation 7.29 |
| Sentinel Cohort | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 2 | 2.2 Alkaline Phosphatase (U/L) | Standard Deviation 7.36 |
| Main Cohort Group 1 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 28 | -0.8 Alkaline Phosphatase (U/L) | Standard Deviation 3.79 |
| Main Cohort Group 1 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 4 | -2.6 Alkaline Phosphatase (U/L) | Standard Deviation 3.06 |
| Main Cohort Group 1 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 7 | 0.8 Alkaline Phosphatase (U/L) | Standard Deviation 8.18 |
| Main Cohort Group 1 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 3 | 0 Alkaline Phosphatase (U/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in Alkaline Phosphatase (U/L) Day 14 | -0.7 Alkaline Phosphatase (U/L) | Standard Deviation 9.29 |
| Main Cohort Group 2 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 3 | -0.9 Alkaline Phosphatase (U/L) | Standard Deviation 2.13 |
| Main Cohort Group 2 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 28 | 7.0 Alkaline Phosphatase (U/L) | Standard Deviation 11.37 |
| Main Cohort Group 2 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 4 | 0 Alkaline Phosphatase (U/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in Alkaline Phosphatase (U/L) Day 14 | 1.2 Alkaline Phosphatase (U/L) | Standard Deviation 7.68 |
| Main Cohort Group 2 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 7 | 2.1 Alkaline Phosphatase (U/L) | Standard Deviation 5.88 |
| Main Cohort Group 3 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 28 | 3.7 Alkaline Phosphatase (U/L) | Standard Deviation 8.9 |
| Main Cohort Group 3 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 3 | -0.8 Alkaline Phosphatase (U/L) | Standard Deviation 2.39 |
| Main Cohort Group 3 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 4 | 0 Alkaline Phosphatase (U/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in alkaline phosphatase (U/L) Day 7 | -2.8 Alkaline Phosphatase (U/L) | Standard Deviation 4.61 |
| Main Cohort Group 3 | Change From Baseline of Alkaline Phosphatase. | Change from baseline in Alkaline Phosphatase (U/L) Day 14 | -2.9 Alkaline Phosphatase (U/L) | Standard Deviation 4.43 |
Primary
Change From Baseline of Prothrombin Intl. Normalized Ratio.
Clinical laboratory safety data will be summarized by laboratory measures like prothrombin intl. normalized ratio. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio day 14 | -0.06 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.055 |
| Sentinel Cohort | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 8 | -0.02 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.045 |
| Sentinel Cohort | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 2 | -0.06 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.055 |
| Main Cohort Group 1 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 28 | 0.00 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.047 |
| Main Cohort Group 1 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 4 | 0.01 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.032 |
| Main Cohort Group 1 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio day 7 | 0.02 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.067 |
| Main Cohort Group 1 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 3 | 0 Prothrombin Intl. Normalized Ratio | Standard Deviation 0 |
| Main Cohort Group 1 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio day 14 | -0.01 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.057 |
| Main Cohort Group 2 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 3 | 0.01 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.057 |
| Main Cohort Group 2 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 28 | 0.02 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.044 |
| Main Cohort Group 2 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 4 | 0 Prothrombin Intl. Normalized Ratio | Standard Deviation 0 |
| Main Cohort Group 2 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio day 14 | 0.00 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.05 |
| Main Cohort Group 2 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio day 7 | 0.01 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.033 |
| Main Cohort Group 3 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 28 | 0 Prothrombin Intl. Normalized Ratio | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 3 | -0.03 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.048 |
| Main Cohort Group 3 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio Day 4 | 0 Prothrombin Intl. Normalized Ratio | Standard Deviation 0 |
| Main Cohort Group 3 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio day 7 | 0.00 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.047 |
| Main Cohort Group 3 | Change From Baseline of Prothrombin Intl. Normalized Ratio. | Change from baseline in prothrombin intl. normalized ratio day 14 | -0.02 Prothrombin Intl. Normalized Ratio | Standard Deviation 0.042 |
Primary
Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score)
The sino-nasal outcome test (SNOT-22) is to measure the consequences of rhinosinusitis. Scores will be totaled for all 22 items. The minimum score on the sinonasal outcome test-22 (SNOT-22) is 0 and the maximum score is 110. Changes from baseline in individual total sinonasal outcome test-22 (SNOT-22) scores will be calculated as the post-baseline value minus the baseline value. Thus, a negative change will reflect an improvement in the corresponding score. Observed values and changes from baseline will be summarized at each scheduled timepoint by treatment using descriptive statistics and tabulated for each cohort (dose level) and overall. Individual symptoms will be listed, with the 5 most important issues flagged. The total SNOT score will also be included in the listing.
Time frame: For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 8 | 2.4 Sinonasal outcome test-22 scores | Standard Deviation 3.36 |
| Sentinel Cohort | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 1 | 2.6 Sinonasal outcome test-22 scores | Standard Deviation 4.83 |
| Main Cohort Group 1 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 28 | 0.7 Sinonasal outcome test-22 scores | Standard Deviation 7.82 |
| Main Cohort Group 1 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 1 | 1.9 Sinonasal outcome test-22 scores | Standard Deviation 1.79 |
| Main Cohort Group 1 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 14 | 3.0 Sinonasal outcome test-22 scores | Standard Deviation 10.54 |
| Main Cohort Group 1 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 7 | -1.0 Sinonasal outcome test-22 scores | Standard Deviation 3.12 |
| Main Cohort Group 2 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 14 | -3.0 Sinonasal outcome test-22 scores | Standard Deviation 3.82 |
| Main Cohort Group 2 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 28 | -3.6 Sinonasal outcome test-22 scores | Standard Deviation 3.93 |
| Main Cohort Group 2 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 7 | -2.1 Sinonasal outcome test-22 scores | Standard Deviation 4.29 |
| Main Cohort Group 2 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 1 | 1.4 Sinonasal outcome test-22 scores | Standard Deviation 2.17 |
| Main Cohort Group 3 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 28 | -0.5 Sinonasal outcome test-22 scores | Standard Deviation 2.32 |
| Main Cohort Group 3 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 1 | 1.1 Sinonasal outcome test-22 scores | Standard Deviation 1.2 |
| Main Cohort Group 3 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 7 | 3.4 Sinonasal outcome test-22 scores | Standard Deviation 6.8 |
| Main Cohort Group 3 | Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) | Change from baseline in SNOT-22 scores - Day 14 | 3.3 Sinonasal outcome test-22 scores | Standard Deviation 7.47 |
Primary
Changes From Baseline of Hematocrit.
Clinical laboratory safety data will be summarized by laboratory measures such as hematocrit. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 14 | 0.000 Hematocrit (g/L) | Standard Deviation 0.0381 |
| Sentinel Cohort | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 8 | 0.006 Hematocrit (g/L) | Standard Deviation 0.027 |
| Sentinel Cohort | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 2 | 0.016 Hematocrit (g/L) | Standard Deviation 0.0336 |
| Main Cohort Group 1 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 28 | -0.013 Hematocrit (g/L) | Standard Deviation 0.0216 |
| Main Cohort Group 1 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 4 | -0.011 Hematocrit (g/L) | Standard Deviation 0.0292 |
| Main Cohort Group 1 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 7 | -0.006 Hematocrit (g/L) | Standard Deviation 0.0167 |
| Main Cohort Group 1 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 3 | 0 Hematocrit (g/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 14 | -0.019 Hematocrit (g/L) | Standard Deviation 0.0228 |
| Main Cohort Group 2 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 3 | -0.010 Hematocrit (g/L) | Standard Deviation 0.0211 |
| Main Cohort Group 2 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 28 | -0.016 Hematocrit (g/L) | Standard Deviation 0.0265 |
| Main Cohort Group 2 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 4 | 0 Hematocrit (g/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 14 | -0.017 Hematocrit (g/L) | Standard Deviation 0.0141 |
| Main Cohort Group 2 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 7 | -0.031 Hematocrit (g/L) | Standard Deviation 0.0169 |
| Main Cohort Group 3 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 28 | 0.000 Hematocrit (g/L) | Standard Deviation 0.0245 |
| Main Cohort Group 3 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 3 | -0.008 Hematocrit (g/L) | Standard Deviation 0.0217 |
| Main Cohort Group 3 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 4 | 0 Hematocrit (g/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 7 | -0.016 Hematocrit (g/L) | Standard Deviation 0.0232 |
| Main Cohort Group 3 | Changes From Baseline of Hematocrit. | Change from baseline in hematocrit (L/L) Day 14 | -0.011 Hematocrit (g/L) | Standard Deviation 0.0202 |
Primary
Changes From Baseline of Hemoglobin.
Clinical laboratory safety data will be summarized by laboratory measures like hemoglobin. Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Time frame: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28
Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as 0 subjects analyzed for that particular timepoint. Otherwise 0 has been entered where data was not collected for that timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 14 | -2.2 Changes from baseline of hemoglobin(g/L) | Standard Deviation 11.08 |
| Sentinel Cohort | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 8 | -0.8 Changes from baseline of hemoglobin(g/L) | Standard Deviation 7.79 |
| Sentinel Cohort | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 2 | 2.6 Changes from baseline of hemoglobin(g/L) | Standard Deviation 10.04 |
| Main Cohort Group 1 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 28 | -4.7 Changes from baseline of hemoglobin(g/L) | Standard Deviation 5.77 |
| Main Cohort Group 1 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 4 | -1.5 Changes from baseline of hemoglobin(g/L) | Standard Deviation 7.12 |
| Main Cohort Group 1 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 7 | -0.6 Changes from baseline of hemoglobin(g/L) | Standard Deviation 4.28 |
| Main Cohort Group 1 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 3 | 0 Changes from baseline of hemoglobin(g/L) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 14 | -3.2 Changes from baseline of hemoglobin(g/L) | Standard Deviation 5.45 |
| Main Cohort Group 2 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 3 | -2.8 Changes from baseline of hemoglobin(g/L) | Standard Deviation 7.07 |
| Main Cohort Group 2 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 28 | -4.9 Changes from baseline of hemoglobin(g/L) | Standard Deviation 9.44 |
| Main Cohort Group 2 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 4 | 0 Changes from baseline of hemoglobin(g/L) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 14 | -5.4 Changes from baseline of hemoglobin(g/L) | Standard Deviation 5.17 |
| Main Cohort Group 2 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 7 | -9.3 Changes from baseline of hemoglobin(g/L) | Standard Deviation 5.36 |
| Main Cohort Group 3 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 28 | -2.7 Changes from baseline of hemoglobin(g/L) | Standard Deviation 6.53 |
| Main Cohort Group 3 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 3 | -1.3 Changes from baseline of hemoglobin(g/L) | Standard Deviation 6.5 |
| Main Cohort Group 3 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 4 | 0 Changes from baseline of hemoglobin(g/L) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 7 | -4.7 Changes from baseline of hemoglobin(g/L) | Standard Deviation 6.25 |
| Main Cohort Group 3 | Changes From Baseline of Hemoglobin. | Change from baseline in hemoglobin (g/L) Day 14 | -3.8 Changes from baseline of hemoglobin(g/L) | Standard Deviation 7.22 |
Primary
Changes From Baseline of Oral Temperature.
Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.
Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 4 hour post-dose | -0.10 Change from baseline of temperature (°C) | Standard Deviation 0.418 |
| Sentinel Cohort | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 1 hour post-dose | -0.42 Change from baseline of temperature (°C) | Standard Deviation 0.228 |
| Sentinel Cohort | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 8 post-dose | -0.34 Change from baseline of temperature (°C) | Standard Deviation 0.658 |
| Sentinel Cohort | Changes From Baseline of Oral Temperature. | Change from baseline in temperature Change from baseline in (°C) - Day 1, 0.5 hour post-dose | -0.42 Change from baseline of temperature (°C) | Standard Deviation 0.476 |
| Sentinel Cohort | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 14 post-dose | -0.32 Change from baseline of temperature (°C) | Standard Deviation 0.653 |
| Sentinel Cohort | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 2 post-dose | -0.34 Change from baseline of temperature (°C) | Standard Deviation 0.297 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 0.25 hour post-dose | -0.15 Change from baseline of temperature (°C) | Standard Deviation 0.381 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature Change from baseline in (°C) - Day 1, 0.5 hour post-dose | 0.01 Change from baseline of temperature (°C) | Standard Deviation 0.185 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 1 hour post-dose | -0.11 Change from baseline of temperature (°C) | Standard Deviation 0.805 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 4 hour post-dose | 0.13 Change from baseline of temperature (°C) | Standard Deviation 0.313 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 3 post-dose | 0 Change from baseline of temperature (°C) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 4 post-dose | -0.8 Change from baseline of temperature (°C) | Standard Deviation 0.437 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 7 post-dose | -0.18 Change from baseline of temperature (°C) | Standard Deviation 0.338 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 10 post-dose | -0.17 Change from baseline of temperature (°C) | Standard Deviation 0.374 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 11 post-dose | 0 Change from baseline of temperature (°C) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 14 post-dose | -0.22 Change from baseline of temperature (°C) | Standard Deviation 0.424 |
| Main Cohort Group 1 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 28 post-dose | -0.18 Change from baseline of temperature (°C) | Standard Deviation 0.394 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 3 post-dose | -0.25 Change from baseline of temperature (°C) | Standard Deviation 0.788 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 28 post-dose | -0.39 Change from baseline of temperature (°C) | Standard Deviation 0.446 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 4 post-dose | 0 Change from baseline of temperature (°C) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 14 post-dose | 0.02 Change from baseline of temperature (°C) | Standard Deviation 0.549 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 7 post-dose | -0.10 Change from baseline of temperature (°C) | Standard Deviation 0.424 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 10 post-dose | 0 Change from baseline of temperature (°C) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 11 post-dose | -0.10 Change from baseline of temperature (°C) | Standard Deviation 0.274 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 1 hour post-dose | -0.02 Change from baseline of temperature (°C) | Standard Deviation 0.322 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 4 hour post-dose | -0.34 Change from baseline of temperature (°C) | Standard Deviation 0.488 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature Change from baseline in (°C) - Day 1, 0.5 hour post-dose | -0.1 Change from baseline of temperature (°C) | Standard Deviation 0.613 |
| Main Cohort Group 2 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 0.25 hour post-dose | -0.04 Change from baseline of temperature (°C) | Standard Deviation 0.388 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 10 post-dose | 0 Change from baseline of temperature (°C) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 3 post-dose | 0.18 Change from baseline of temperature (°C) | Standard Deviation 0.368 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 28 post-dose | 0.25 Change from baseline of temperature (°C) | Standard Deviation 0.517 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 11 post-dose | 0.17 Change from baseline of temperature (°C) | Standard Deviation 0.353 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 4 post-dose | 0 Change from baseline of temperature (°C) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 4 hour post-dose | 0.16 Change from baseline of temperature (°C) | Standard Deviation 0.422 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 1 hour post-dose | 0.14 Change from baseline of temperature (°C) | Standard Deviation 0.327 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 7 post-dose | 0.27 Change from baseline of temperature (°C) | Standard Deviation 0.35 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 1, 0.25 hour post-dose | 0.13 Change from baseline of temperature (°C) | Standard Deviation 0.347 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature (°C) - Day 14 post-dose | 0.33 Change from baseline of temperature (°C) | Standard Deviation 0.472 |
| Main Cohort Group 3 | Changes From Baseline of Oral Temperature. | Change from baseline in temperature Change from baseline in (°C) - Day 1, 0.5 hour post-dose | 0.17 Change from baseline of temperature (°C) | Standard Deviation 0.46 |
Primary
Changes From Baseline of Pulse Rate.
Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.
Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 4 hours post-dose | 1.4 Change from baseline of pulse rate | Standard Deviation 2.7 |
| Sentinel Cohort | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 1 hour post-dose | -7.0 Change from baseline of pulse rate | Standard Deviation 1.87 |
| Sentinel Cohort | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 8 post-dose | 3.4 Change from baseline of pulse rate | Standard Deviation 8.29 |
| Sentinel Cohort | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 0.5 hour post-dose | -4.8 Change from baseline of pulse rate | Standard Deviation 3.27 |
| Sentinel Cohort | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 14 post-dose | 4.6 Change from baseline of pulse rate | Standard Deviation 8.32 |
| Sentinel Cohort | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 2 post-dose | 3.4 Change from baseline of pulse rate | Standard Deviation 7.27 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 0.25 hour post-dose | -4.2 Change from baseline of pulse rate | Standard Deviation 7.51 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 0.5 hour post-dose | -5.4 Change from baseline of pulse rate | Standard Deviation 6.4 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 1 hour post-dose | -3.0 Change from baseline of pulse rate | Standard Deviation 8.7 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 4 hours post-dose | 3.1 Change from baseline of pulse rate | Standard Deviation 7.8 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 3 post-dose | 0 Change from baseline of pulse rate | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 4 post-dose | -0.5 Change from baseline of pulse rate | Standard Deviation 6.26 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 7 post-dose | 5.0 Change from baseline of pulse rate | Standard Deviation 10.12 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 10 post-dose | 5.4 Change from baseline of pulse rate | Standard Deviation 11.1 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 11 post-dose | 0 Change from baseline of pulse rate | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 14 post-dose | 3.2 Change from baseline of pulse rate | Standard Deviation 7.22 |
| Main Cohort Group 1 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 28 post-dose | 1.5 Change from baseline of pulse rate | Standard Deviation 6.67 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 3 post-dose | 2.7 Change from baseline of pulse rate | Standard Deviation 7.12 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 28 post-dose | -1.4 Change from baseline of pulse rate | Standard Deviation 5.96 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 4 post-dose | 0 Change from baseline of pulse rate | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 14 post-dose | 6.7 Change from baseline of pulse rate | Standard Deviation 6.02 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 7 post-dose | 8.3 Change from baseline of pulse rate | Standard Deviation 8.29 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 10 post-dose | 0 Change from baseline of pulse rate | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 11 post-dose | 6.3 Change from baseline of pulse rate | Standard Deviation 4.85 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 1 hour post-dose | -4.0 Change from baseline of pulse rate | Standard Deviation 4.59 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 4 hours post-dose | 3.1 Change from baseline of pulse rate | Standard Deviation 4.23 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 0.5 hour post-dose | -4.6 Change from baseline of pulse rate | Standard Deviation 2.99 |
| Main Cohort Group 2 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 0.25 hour post-dose | -5.0 Change from baseline of pulse rate | Standard Deviation 3.32 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 10 post-dose | 0 Change from baseline of pulse rate | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 3 post-dose | -1.8 Change from baseline of pulse rate | Standard Deviation 4.21 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 28 post-dose | -1.5 Change from baseline of pulse rate | Standard Deviation 7.31 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 11 post-dose | -2.0 Change from baseline of pulse rate | Standard Deviation 3.33 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 4 post-dose | 0 Change from baseline of pulse rate | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 4 hours post-dose | 2.6 Change from baseline of pulse rate | Standard Deviation 7.21 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 1 hour post-dose | -5.0 Change from baseline of pulse rate | Standard Deviation 5.08 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 7 post-dose | 0.8 Change from baseline of pulse rate | Standard Deviation 8.05 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 0.25 hour post-dose | -3.0 Change from baseline of pulse rate | Standard Deviation 4.11 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 14 post-dose | 2.3 Change from baseline of pulse rate | Standard Deviation 2.36 |
| Main Cohort Group 3 | Changes From Baseline of Pulse Rate. | Change from baseline in pulse rate (beats/min ) - Day 1, 0.5 hour post-dose | -4.0 Change from baseline of pulse rate | Standard Deviation 5.98 |
Primary
Changes From Baseline of QRS Duration, Single Beat (ms).
The following ECG parameters will be analyzed: QRS duration, single beat (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).
Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of QRS Duration, Single Beat (ms). | Change from baseline in QRS duration (ms) Day 14 | 2.06 QRS duration, single beat (ms) | Standard Deviation 4.21 |
| Main Cohort Group 1 | Changes From Baseline of QRS Duration, Single Beat (ms). | Change from baseline in QRS duration (ms) Day 28 | 2.24 QRS duration, single beat (ms) | Standard Deviation 2.78 |
| Main Cohort Group 2 | Changes From Baseline of QRS Duration, Single Beat (ms). | Change from baseline in QRS duration (ms) Day 28 | 0.38 QRS duration, single beat (ms) | Standard Deviation 5.77 |
| Main Cohort Group 3 | Changes From Baseline of QRS Duration, Single Beat (ms). | Change from baseline in QRS duration (ms) Day 28 | -1.95 QRS duration, single beat (ms) | Standard Deviation 5.17 |
Primary
Changes From Baseline of Respiratory Rate.
Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: In part A respiratory rate is measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.
Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 4 hours post-dose | -0.8 Respiratory rate (breaths per minute) | Standard Deviation 1.1 |
| Sentinel Cohort | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 1 hours post-dose | -0.8 Respiratory rate (breaths per minute) | Standard Deviation 1.1 |
| Sentinel Cohort | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 8 post-dose | -2.4 Respiratory rate (breaths per minute) | Standard Deviation 1.67 |
| Sentinel Cohort | Changes From Baseline of Respiratory Rate. | Change from baseline in Respiratory Rate (breaths/minute) - Day 1, 0.5 hour post-dose | -3.6 Respiratory rate (breaths per minute) | Standard Deviation 2.19 |
| Sentinel Cohort | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 14 post-dose | -1.6 Respiratory rate (breaths per minute) | Standard Deviation 0.89 |
| Sentinel Cohort | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 2 post-dose | -2.4 Respiratory rate (breaths per minute) | Standard Deviation 1.67 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 0.25 hours post-dose | -0.5 Respiratory rate (breaths per minute) | Standard Deviation 2.88 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in Respiratory Rate (breaths/minute) - Day 1, 0.5 hour post-dose | 0.3 Respiratory rate (breaths per minute) | Standard Deviation 2.58 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 1 hours post-dose | -1.0 Respiratory rate (breaths per minute) | Standard Deviation 1.58 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 4 hours post-dose | 0.3 Respiratory rate (breaths per minute) | Standard Deviation 1.77 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 3 post-dose | 0 Respiratory rate (breaths per minute) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 4 post-dose | 0.1 Respiratory rate (breaths per minute) | Standard Deviation 1.79 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 7 post-dose | 0.1 Respiratory rate (breaths per minute) | Standard Deviation 1.27 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 10 post-dose | 15.3 Respiratory rate (breaths per minute) | Standard Deviation 1.41 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 11 post-dose | 0 Respiratory rate (breaths per minute) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 14 post-dose | -1.1 Respiratory rate (breaths per minute) | Standard Deviation 1.37 |
| Main Cohort Group 1 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 28 post-dose | -0.3 Respiratory rate (breaths per minute) | Standard Deviation 2 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 3 post-dose | -1.8 Respiratory rate (breaths per minute) | Standard Deviation 3.08 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 28 post-dose | -1.6 Respiratory rate (breaths per minute) | Standard Deviation 2.4 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 4 post-dose | 0 Respiratory rate (breaths per minute) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 14 post-dose | -2.0 Respiratory rate (breaths per minute) | Standard Deviation 2.45 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 7 post-dose | -1.3 Respiratory rate (breaths per minute) | Standard Deviation 1.73 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 10 post-dose | 0 Respiratory rate (breaths per minute) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 11 post-dose | -1.6 Respiratory rate (breaths per minute) | Standard Deviation 2.13 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 1 hours post-dose | -1.8 Respiratory rate (breaths per minute) | Standard Deviation 2.39 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 4 hours post-dose | -1.1 Respiratory rate (breaths per minute) | Standard Deviation 1.79 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in Respiratory Rate (breaths/minute) - Day 1, 0.5 hour post-dose | -2.9 Respiratory rate (breaths per minute) | Standard Deviation 2.33 |
| Main Cohort Group 2 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 0.25 hours post-dose | -3.1 Respiratory rate (breaths per minute) | Standard Deviation 2.67 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 10 post-dose | 0 Respiratory rate (breaths per minute) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 3 post-dose | -1.1 Respiratory rate (breaths per minute) | Standard Deviation 1.6 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 28 post-dose | -0.1 Respiratory rate (breaths per minute) | Standard Deviation 1.85 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 11 post-dose | 1.3 Respiratory rate (breaths per minute) | Standard Deviation 2.16 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 4 post-dose | 0 Respiratory rate (breaths per minute) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 4 hours post-dose | 1.4 Respiratory rate (breaths per minute) | Standard Deviation 2.32 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 1 hours post-dose | -0.6 Respiratory rate (breaths per minute) | Standard Deviation 1.71 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 7 post-dose | 0.1 Respiratory rate (breaths per minute) | Standard Deviation 1.73 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 1, 0.25 hours post-dose | -0.3 Respiratory rate (breaths per minute) | Standard Deviation 1.16 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in respiratory rate (breaths/minute) - Day 14 post-dose | -1.3 Respiratory rate (breaths per minute) | Standard Deviation 1.83 |
| Main Cohort Group 3 | Changes From Baseline of Respiratory Rate. | Change from baseline in Respiratory Rate (breaths/minute) - Day 1, 0.5 hour post-dose | 0.3 Respiratory rate (breaths per minute) | Standard Deviation 1.95 |
Primary
Changes From Baseline of Single RR Heart Rate (Beats/Min).
The following ECG parameters will be analyzed: single RR heart rate (beats/min). Observed values and changes from baseline for single RR heart rate (beats/min). will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).
Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of Single RR Heart Rate (Beats/Min). | Change from baseline in single RR heart rate (beats/min) Day 14 | 5.00 Single RR heart rate (beats/min) | Standard Deviation 3.94 |
| Main Cohort Group 1 | Changes From Baseline of Single RR Heart Rate (Beats/Min). | Change from baseline in single RR heart rate (beats/min) Day 28 | 3.08 Single RR heart rate (beats/min) | Standard Deviation 8.16 |
| Main Cohort Group 2 | Changes From Baseline of Single RR Heart Rate (Beats/Min). | Change from baseline in single RR heart rate (beats/min) Day 28 | 0.54 Single RR heart rate (beats/min) | Standard Deviation 6.61 |
| Main Cohort Group 3 | Changes From Baseline of Single RR Heart Rate (Beats/Min). | Change from baseline in single RR heart rate (beats/min) Day 28 | 2.29 Single RR heart rate (beats/min) | Standard Deviation 7.01 |
Primary
Changes From Baseline of Systolic and Diastolic Blood Pressure.
Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics.
Time frame: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.
Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 4 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 4 hours post-dose | 5.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.61 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 2 post-dose | 0.0 Delta from baseline blood pressure(mmHg) | Standard Deviation 4.18 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | 2.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 4.76 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 1 hour post-dose | 1.0 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.21 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure - Day 1, 4 hours post-dose | 1.0 Delta from baseline blood pressure(mmHg) | Standard Deviation 10.32 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 2 | -0.6 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.32 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 8 | -1.6 Delta from baseline blood pressure(mmHg) | Standard Deviation 4.39 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 1 hour post-dose | -1.8 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.58 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic change from baseline in blood pressure (mmHg) - Day 8 | 0.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 15.92 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | 0.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.08 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 14 | 1.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.79 |
| Sentinel Cohort | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 14 | 1.6 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.77 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 11 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 1 hour post-dose | -1.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 9.88 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose | 1.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 11.21 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 3 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 28 | 0.0 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.33 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 10 | 0.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.51 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 4 | -1.6 Delta from baseline blood pressure(mmHg) | Standard Deviation 10.56 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 14 | 1.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 9.79 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 11 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic from baseline in blood pressure (mmHg) - Day 7 | 2.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 14.13 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 28 | 1.6 Delta from baseline blood pressure(mmHg) | Standard Deviation 14.8 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 14 | 3.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 15.06 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 3 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose | 0.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.11 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 4 hours post-dose | 4.7 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.53 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 7 | -0.3 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.09 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 4 | 0.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.31 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | -2.7 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.87 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | -1.7 Delta from baseline blood pressure(mmHg) | Standard Deviation 10.13 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure - Day 1, 4 hours post-dose | -2.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.99 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 10 | 1.3 Delta from baseline blood pressure(mmHg) | Standard Deviation 11.68 |
| Main Cohort Group 1 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 1 hour post-dose | -1.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.09 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 4 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose | -1.3 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.22 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | -2.8 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.02 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 1 hour post-dose | -2.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.39 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 4 hours post-dose | -1.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.33 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 3 | -4.3 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.33 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 4 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic from baseline in blood pressure (mmHg) - Day 7 | -3.8 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.51 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 10 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 11 | -6.6 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.65 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 14 | -4.0 Delta from baseline blood pressure(mmHg) | Standard Deviation 9.23 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 28 | -3.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.56 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose | -0.6 Delta from baseline blood pressure(mmHg) | Standard Deviation 3.91 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | -2.0 Delta from baseline blood pressure(mmHg) | Standard Deviation 4.78 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 1 hour post-dose | -1.8 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.18 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure - Day 1, 4 hours post-dose | -2.5 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.66 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 3 | -3.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.47 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 7 | -3.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.88 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 10 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 11 | -6.0 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.4 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 14 | -2.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.7 |
| Main Cohort Group 2 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 28 | -3.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.25 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 3 | -1.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.56 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 14 | -1.5 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.96 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 11 | -2.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.92 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 10 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 4 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic from baseline in blood pressure (mmHg) - Day 7 | -4.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 7 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 28 | 4.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.19 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 7 | -1.1 Delta from baseline blood pressure(mmHg) | Standard Deviation 4.72 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 4 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 3 | -1.5 Delta from baseline blood pressure(mmHg) | Standard Deviation 9 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 14 | 0.7 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.63 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 10 | 0 Delta from baseline blood pressure(mmHg) | Standard Deviation 0 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 4 hours post-dose | 1.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.07 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose | -2.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 4.5 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 11 | -0.7 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.99 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 1 hour post-dose | 0.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.26 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | -1.8 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.37 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 1 hour post-dose | -0.9 Delta from baseline blood pressure(mmHg) | Standard Deviation 5.11 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure - Day 1, 4 hours post-dose | -0.4 Delta from baseline blood pressure(mmHg) | Standard Deviation 7.88 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose | 0.3 Delta from baseline blood pressure(mmHg) | Standard Deviation 6.6 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 28 | 2.2 Delta from baseline blood pressure(mmHg) | Standard Deviation 8.57 |
| Main Cohort Group 3 | Changes From Baseline of Systolic and Diastolic Blood Pressure. | Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose | -2.5 Delta from baseline blood pressure(mmHg) | Standard Deviation 10.81 |
Primary
Number of Participants Discontinuing From the Study
The endpoint is the number of participants discontinuing from the study.
Time frame: For 28 days after the first dose of LMN-301
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sentinel Cohort | Number of Participants Discontinuing From the Study | 0 Participants |
| Main Cohort Group 1 | Number of Participants Discontinuing From the Study | 0 Participants |
| Main Cohort Group 2 | Number of Participants Discontinuing From the Study | 1 Participants |
| Main Cohort Group 3 | Number of Participants Discontinuing From the Study | 0 Participants |
Primary
Number of Participants With Adverse Events
All adverse events (AEs) will be coded using the latest version of MedDRA by system organ class (SOC) and preferred term, classified from verbatim terms. The number of treatment-emergent AEs (TEAEs) as well as the number and percentage of participants with at least one TEAE, will be summarized by SOC and preferred term. Summaries of TEAEs by severity as assessed by CTCAE v5.0 and relationship will also be presented. Summaries will also be presented for serious adverse events (SAEs), TEAEs leading to death or study withdrawal. The duration of all AEs will be determined and included in the listings. Solicited and unsolicited TEAEs will be summarized separately.
Time frame: Daily for 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sentinel Cohort | Number of Participants With Adverse Events | 5 Participants |
| Main Cohort Group 1 | Number of Participants With Adverse Events | 9 Participants |
| Main Cohort Group 2 | Number of Participants With Adverse Events | 10 Participants |
| Main Cohort Group 3 | Number of Participants With Adverse Events | 8 Participants |