Trial Outcomes & Findings for A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants (NCT NCT04988152)
NCT ID: NCT04988152
Last Updated: 2024-06-07
Results Overview
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric means and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using analysis of covariance (ANCOVA) adjusting for body weight. The geometric Least Square (LS) means ratio (Japanese versus Caucasian) for Cmax and 90 percent (%) confidence interval (CI) are presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 1: Pre-dose, at end of infusion (EOI) and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29
Results posted on
2024-06-07
Participant Flow
This study was conducted in the United States.
A total of 48 participants (24 participants in Part 1 and 24 participants in Part 2) were enrolled in the study (Safety Population comprised of all randomized participants who were exposed to study intervention).
Participant milestones
| Measure |
Part 1: Placebo IV (Japanese)
Japanese participants received a volume-matched saline placebo (Sterile 0.9 percent \[%\] weight/volume \[w/v\] sodium chloride solution) matching intravenous (IV) infusion of sotrovimab on Day 1.
|
Part 1:Placebo IV (Caucasian)
Caucasian participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
Part 2: Placebo IM (Japanese)
Japanese participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching intramuscular (IM) injection of sotrovimab on Day 1.
|
Part 2: Placebo IM (Caucasian)
Caucasian participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching IM injection of sotrovimab on Day 1.
|
Part 2: Sotrovimab 500 mg IM (Japanese)
Japanese participants received a single 500 mg IM injection of sotrovimab (administered as two 4 milliliters \[mL\] injections, one in each dorsogluteal muscle) on Day 1.
|
Part 2: Sotrovimab 500 mg IM (Caucasian)
Caucasian participants received a single 500 mg IM injection of sotrovimab (administered as two 4 mL injections, one in each dorsogluteal muscle) on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Up to Week 18)
STARTED
|
3
|
3
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Part 1 (Up to Week 18)
COMPLETED
|
3
|
3
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Part 1 (Up to Week 18)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to Week 18)
STARTED
|
0
|
0
|
0
|
0
|
2
|
2
|
10
|
10
|
|
Part 2 (Up to Week 18)
COMPLETED
|
0
|
0
|
0
|
0
|
2
|
2
|
10
|
10
|
|
Part 2 (Up to Week 18)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants
Baseline characteristics by cohort
| Measure |
Part 1: Placebo IV (Japanese)
n=3 Participants
Japanese participants received a volume-matched saline placebo (Sterile 0.9 percent \[%\] weight/volume \[w/v\] sodium chloride solution) matching intravenous (IV) infusion of sotrovimab on Day 1.
|
Part 1:Placebo IV (Caucasian)
n=3 Participants
Caucasian participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
Part 2: Placebo IM (Japanese)
n=2 Participants
Japanese participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching intramuscular (IM) injection of sotrovimab on Day 1.
|
Part 2: Placebo IM (Caucasian)
n=2 Participants
Caucasian participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching IM injection of sotrovimab on Day 1.
|
Part 2: Sotrovimab 500 mg IM (Japanese)
n=10 Participants
Japanese participants received a single 500 mg IM injection of sotrovimab (administered as two 4 milliliters \[mL\] injections, one in each dorsogluteal muscle) on Day 1.
|
Part 2: Sotrovimab 500 mg IM (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IM injection of sotrovimab (administered as two 4 mL injections, one in each dorsogluteal muscle) on Day 1.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Participants · <=18 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
Participants · 19-64 Years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
|
Age, Customized
Participants · >=65 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Participants · ASIAN-JAPANESE HERITAGE
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Participants · WHITE-WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion (EOI) and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29Population: Pharmacokinetic Population comprised all participants in the Safety Population (All randomized participants who were exposed to study intervention) who had at least 1 non-missing PK assessment.
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric means and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using analysis of covariance (ANCOVA) adjusting for body weight. The geometric Least Square (LS) means ratio (Japanese versus Caucasian) for Cmax and 90 percent (%) confidence interval (CI) are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Maximum Observed Serum Concentration (Cmax) of Sotrovimab Through Day 29
|
238.32 Micrograms per milliliter
Geometric Coefficient of Variation 18.5
|
188.66 Micrograms per milliliter
Geometric Coefficient of Variation 13.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29Population: Pharmacokinetic Population
The AUC (D1-29) was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for AUC(D1-29) and 90% Confidence Interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Area Under the Serum-concentration Time Curve From Day 1 to Day 29 (AUC[D1-29]) of Sotrovimab
|
2699.29 Day*micrograms per milliliter
Geometric Coefficient of Variation 11.5
|
2154.90 Day*micrograms per milliliter
Geometric Coefficient of Variation 9.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29Population: Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. Participants with slow drug distribution following IV infusion were excluded.
The Tmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=8 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Time to Cmax (Tmax) of Sotrovimab Through Day 29
|
1.567 Hours
Interval 1.55 to 6.55
|
0.733 Hours
Interval 0.68 to 1.58
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Days 8, 15 and 29Population: Pharmacokinetic Population
The CD29 was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Concentration at Day 29 (CD29) Following Administration of Sotrovimab
|
71.48 Micrograms per milliliter
Geometric Coefficient of Variation 15.1
|
55.56 Micrograms per milliliter
Geometric Coefficient of Variation 9.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29Population: Pharmacokinetic Population
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for Cmax and 90% confidence interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Cmax of Sotrovimab Through Day 29
|
60.33 Micrograms per milliliter
Geometric Coefficient of Variation 32.0
|
32.27 Micrograms per milliliter
Geometric Coefficient of Variation 50.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29Population: Pharmacokinetic Population
The AUC (D1-29) was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for AUC(D1-29) and 90% confidence interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: AUC(D1-29) of Sotrovimab
|
1378.28 Day*micrograms per milliliter
Geometric Coefficient of Variation 28.1
|
743.39 Day*micrograms per milliliter
Geometric Coefficient of Variation 46.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29Population: Pharmacokinetic Population
The Tmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Tmax of Sotrovimab Through Day 29
|
168.88 Hours
Interval 167.8 to 334.1
|
166.60 Hours
Interval 165.4 to 696.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Days 8, 15 and 29Population: Pharmacokinetic Population
The CD29 was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: CD29 of Sotrovimab
|
44.5 Micrograms per milliliter
Geometric Coefficient of Variation 30.5
|
29.14 Micrograms per milliliter
Geometric Coefficient of Variation 50.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population comprised of all randomized participants who were exposed to study intervention.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Adverse events which were not serious adverse events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Serious Adverse Events (SAE) and Common Non-serious Adverse Events (Non-SAE) Through Day 29
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Serious Adverse Events (SAE) and Common Non-serious Adverse Events (Non-SAE) Through Day 29
Non-SAE
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Adverse events of special interest (AESI) are relevant known toxicities of other therapeutic monoclonal antibodies (mAbs) or signals observed in nonclinical programs of sotrovimab. AESI were defined as Infusion-related reactions (IRR) including hypersensitivity reactions, Hypersensitivity Standardized Medical dictionary for Regulatory Activities (MedDRA) Queries (SMQ) narrow, Infusion site reactions, Immunogenicity related adverse drug reactions (ADR) and AE potentially related to antibody-dependent enhancement of disease (ADE). Only IRR including hypersensitivity and Infusion site reactions through Day 29 were summarized.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29
IRR including hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29
Infusion Site Reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Twelve-lead ECG's were obtained in the semi-recumbent or supine position after 10 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant worst case post-Baseline ECG findings were reported.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings Through Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 29Population: Safety Population
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a semi-supine or sitting position after 5 minutes rest. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Data is presented for only those parameters for which participants had grade shifts from Baseline grade. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 29Population: Safety Population
Blood samples were collected for analysis of clinical chemistry parameters including Total Bilirubin, Direct Bilirubin, Glucose (fasting) and Glucose. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Data is presented for only those parameters for which participants had grade shifts from Baseline grade. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Total Bilirubin, High, Grade 0 to Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Direct Bilirubin, High, Grade 0 to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Glucose (fasting), High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Glucose (fasting), High, Grade 0 to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Glucose, Low, Grade 1 to Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 29Population: Safety Population
Urine samples were collected for analysis of bilirubin, leukocyte esterase, occult blood, and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value on or after Day -1 visit, including those from unscheduled visits. Any increase means any increase to small, moderate, severe, potentially life threatening or positive post-Baseline relative to Baseline. Data is presented for only those parameters for which participants had any increase in urinalysis results post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Bilirubin
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Leukocyte Esterase
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Occult Blood
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Protein
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 2: Number of participants with SAE and common non-SAE through Day 29Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Adverse events which were not serious adverse events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With SAE and Common Non-SAE Through Day 29
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With SAE and Common Non-SAE Through Day 29
Non-SAE
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Adverse events of special interest (AESI) are relevant known toxicities of other therapeutic mAbs or signals observed in nonclinical programs of sotrovimab. AESI were defined as Injection-related reactions including hypersensitivity reactions, Hypersensitivity (SMQ narrow), Injection site reactions, Immunogenicity related adverse drug reactions (ADR) and AE potentially related to antibody-dependent enhancement of disease (ADE). Only Injection-related reactions including hypersensitivity and Injection site reactions through Day 29 were summarized.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With AESI Through Day 29
Injection-related reactions including hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With AESI Through Day 29
Injection Site Reaction
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Twelve-lead ECG's were obtained in the semi-recumbent or supine position after 10 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant worst case post-Baseline ECG findings were reported.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant ECG Findings Through Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day) and up to Day 29Population: Safety Population
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine or sitting position after 5 minutes rest. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Day 29
DBP; Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Day 29
SBP; Grade 1 to Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Day 29
Pulse rate; Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 29Population: Safety Population
Blood samples were collected for analysis of clinical chemistry parameters including Alkaline Phosphatase (ALP), Total Bilirubin, Glucose, Potassium and Sodium. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Data is presented for only those parameters for which participants had grade shifts from Baseline grade. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Glucose, Low, Grade 0 to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
ALP, High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Potassium, High, Grade 0 to Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Sodium, Low, Grade 1 to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Day 29
Total Bilirubin, High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 29Population: Safety Population
Urine samples were collected for analysis of bilirubin, glucose, leukocyte esterase, occult blood and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value on or after Day -1 visit, including those from unscheduled visits. Any increase means any increase to small, moderate, severe, potentially life threatening or positive post-Baseline relative to Baseline. Data is presented for only those parameters for which participants had any increase in urinalysis results post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Bilirubin
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Leukocyte Esterase
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Occult Blood
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Protein
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Day 29
Glucose
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for Cmax and 90% confidence interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Cmax of Sotrovimab Through Week 18
|
238.32 Micrograms per milliliter
Geometric Coefficient of Variation 18.5
|
188.66 Micrograms per milliliter
Geometric Coefficient of Variation 13.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. Participants with the extrapolated portion of AUCinfinity (% AUCex) \>20% were excluded.
The AUC(0-infinity) was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Area Under the Serum Concentration-time Curve Extrapolated to Infinite Time (AUC[0-infinity]) of Sotrovimab Through Week 18
|
7513.23 Day*micrograms per milliliter
Geometric Coefficient of Variation 22.1
|
5388.17 Day*micrograms per milliliter
Geometric Coefficient of Variation 30.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The AUClast was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for AUClast and 90% Confidence Interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of Sotrovimab Through Week 18
|
6597.35 Day*micrograms per milliliter
Geometric Coefficient of Variation 10.9
|
5098.64 Day*micrograms per milliliter
Geometric Coefficient of Variation 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. Participants with slow drug distribution following IV infusion were excluded.
The Tmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=8 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Tmax of Sotrovimab Through Week 18
|
0.065 Day
Interval 0.06 to 0.27
|
0.031 Day
Interval 0.03 to 0.07
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, at end of infusion and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after end of infusion; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The Tlast was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Time of the Last Quantifiable Concentration (Tlast) of Sotrovimab Through Week 18
|
125.98 Day
Interval 119.0 to 126.1
|
125.98 Day
Interval 125.0 to 127.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The T1/2 was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Terminal Elimination Half-life (t1/2) of Sotrovimab Through Week 18
|
56.38 Day
Interval 40.9 to 65.7
|
58.85 Day
Interval 33.6 to 113.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for Cmax and 90% Confidence Interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Cmax of Sotrovimab Through Week 18
|
60.33 Micrograms per milliliter
Geometric Coefficient of Variation 32.0
|
32.27 Micrograms per milliliter
Geometric Coefficient of Variation 50.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. Participants with the extrapolated portion of AUCinfinity (% AUCex) \>20% were excluded.
The AUC0-infinity was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=1 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: AUC(0-infinity) of Sotrovimab Through Week 18
|
5687.48 Day*micrograms per milliliter
Geometric Coefficient of Variation NA
NA indicates that data was not available as geometric coefficient of variation could not be calculated for a single participant.
|
2788.57 Day*micrograms per milliliter
Geometric Coefficient of Variation 60.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The AUClast was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric mean and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using ANCOVA adjusting for body weight. The geometric LS means ratio (Japanese versus Caucasian) for AUClast and 90% Confidence Interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: AUClast of Sotrovimab Through Week 18
|
4018.36 Day*micrograms per milliliter
Geometric Coefficient of Variation 25.1
|
2148.93 Day*micrograms per milliliter
Geometric Coefficient of Variation 39.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The Tmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Tmax of Sotrovimab Through Week 18
|
7.04 Day
Interval 7.0 to 13.9
|
6.94 Day
Interval 6.9 to 29.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 1, 2, 6, 8, 24 (Day 2) and 48 (Day 3) hours after first IM injection; Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population
The Tlast was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Tlast of Sotrovimab Through Week 18
|
127.54 Day
Interval 125.9 to 129.0
|
125.52 Day
Interval 118.9 to 132.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 3, 4, 6, 8, 12 and 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. Participants with adjusted regression coefficient for the slope of elimination phase (R\^2) \<0.8 were excluded.
The T1/2 was summarized using standard non-compartmental pharmacokinetic analysis methods. The median and full range are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: T1/2 of Sotrovimab Through Week 18
|
67.28 Day
Interval 53.2 to 85.5
|
67.40 Day
Interval 48.6 to 89.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Adverse events which were not serious adverse events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With SAE and Common Non-SAE Through Week 18
Non-SAE
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With SAE and Common Non-SAE Through Week 18
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Safety Population
Adverse events of special interest (AESI) are relevant known toxicities of other therapeutic mAbs or signals observed in nonclinical programs of sotrovimab. AESI were defined as Infusion-related reactions (IRR) including hypersensitivity reactions, Hypersensitivity (SMQ narrow), Infusion site reactions, Immunogenicity related adverse drug reactions (ADR) and AE potentially related to antibody-dependent enhancement of disease (ADE).
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With AESI Through Week 18
Infusion Site Reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With AESI Through Week 18
IRR including hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With AESI Through Week 18
Hypersensitivity (SMQ narrow)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With AESI Through Week 18
Immunogenicity related ADR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With AESI Through Week 18
AE potentially related to ADE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Safety Population
Twelve-lead ECG's were obtained in the semi-recumbent or supine position after 10 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant worst case post-Baseline ECG findings were reported.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant ECG Findings Through Week 18
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 18Population: Safety Population
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine or sitting position after 5 minutes rest. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Data is presented for only those parameters for which participants had grade shifts from Baseline grade. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Week 18
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 18Population: Safety Population
Blood samples were collected for analysis of clinical chemistry parameters including Aspartate Aminotransferase (AST), Total Bilirubin, Direct Bilirubin, Glucose (fasting), Glucose and Sodium. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Data is presented for only those parameters for which participants had grade shifts from Baseline grade. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
AST, High, Grade 0 to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
Total Bilirubin, High, Grade 0 to Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
Total Bilirubin, High, Grade 0 to Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
Direct Bilirubin, High, Grade 0 to Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
Glucose (fasting), High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
Glucose (fasting), High, Grade 0 to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
Glucose, Low, Grade 1 to Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinical Chemistry Shifts From Baseline Grade Through Week 18
Sodium, Low, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 18Population: Safety Population
Urine samples were collected for analysis of bilirubin, leukocyte esterase, occult blood and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value on or after Day -1 visit, including those from unscheduled visits. Any increase means any increase to small, moderate, severe, potentially life threatening or positive post-Baseline relative to Baseline. Data is presented for only those parameters for which participants had any increase in urinalysis results post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=3 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=3 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Occult Blood
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Bilirubin
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Leukocyte Esterase
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Protein
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per medical or scientific judgment. Adverse events which were not serious adverse events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With SAE and Common Non-SAE Through Week 18
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With SAE and Common Non-SAE Through Week 18
Non-SAE
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Safety Population
Adverse events of special interest (AESI) are relevant known toxicities of other therapeutic mAbs or signals observed in nonclinical programs of sotrovimab. AESI were defined as Injection-related reactions including hypersensitivity reactions, Hypersensitivity (SMQ narrow), Injection site reactions, Immunogenicity related adverse drug reactions (ADR) and AE potentially related to antibody-dependent enhancement of disease (ADE).
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With AESI Through Week 18
Injection related reaction including hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With AESI Through Week 18
Hypersensitivity (SMQ narrow)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With AESI Through Week 18
Injection Site Reaction
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With AESI Through Week 18
Immunogenicity related ADR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With AESI Through Week 18
AE potentially related to ADE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Safety Population
Twelve 12-lead ECG's were obtained in the semi-recumbent or supine position after 10 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant worst case post-Baseline ECG findings were reported.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant ECG Findings Through Week 18
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 18Population: Safety Population
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine or sitting position after 5 minutes rest. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Data is presented for only those parameters for which participants had grade shifts from Baseline grade. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Week 18
DBP; Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Vital Signs Grade Shifts From Baseline Grade Through Week 18
SBP; Grade 1 to Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 18Population: Safety Population
Blood samples were collected for analysis of clinical chemistry parameters including Alanine aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Total Bilirubin, Creatinine, Glucose (fasting), Glucose, Potassium and Sodium. Baseline is latest pre-dose assessment with a non-missing value on or after Day -1 visit including those from unscheduled visits. Grade Shift from Baseline is defined as shift from any grade (at Baseline) to Grades 1, 2, 3 and 4 post-Baseline. A worst post-Baseline grade shift is defined as worst change that occurred at any measured time point during treatment period. Grading was determined by the Division of Acquired Immunodeficiency Syndrome Table for Grading Severity (DAIDS) version 2.1. Grade 0=Normal, Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4= Potentially Life-Threatening. Data is presented for only those parameters for which participants had grade shifts from Baseline grade. Worst-case post-Baseline shift data is presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
ALT, High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
ALP, High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
AST, High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
Sodium, Low, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
Total Bilirubin, High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
Creatinine, High, Grade 0 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
Glucose (fasting), High, Grade 0 to Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
Glucose, Low, Grade 0 to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
Potassium, High, Grade 0 to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Clinical Chemistry Grade Shifts From Baseline Grade Through Week 18
Sodium, Low, Grade 1 to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 18Population: Safety Population
Urine samples were collected for analysis of bilirubin, glucose, leukocyte esterase, nitrite, occult blood, protein and urobilinogen by a dipstick method. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value on or after Day -1 visit, including those from unscheduled visits. Any increase means any increase to small, moderate, severe, potentially life threatening or positive post-Baseline relative to Baseline. Data is presented for only those parameters for which participants had any increase in urinalysis results post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=2 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=2 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=10 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=10 Participants
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Occult Blood
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Bilirubin
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Glucose
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Leukocyte Esterase
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Nitrite
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Protein
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Any Increase in Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Through Week 18
Urobilinogen
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 (Pre-dose, at end of infusion and 1,2,6,8,24 [Day 2] and 48 [Day 3] hours after end of infusion); Weeks 2,3,4,6,8,12,18; Part 2: Day 1(Pre-dose and 1,2,6,8,24 [Day 2] and 48 [Day 3] hours after first IM injection); Weeks 2,3,4, 6,8,12,18Population: Pharmacokinetic Population. Given that bioavailability assessment requires comparison of exposures between IM and IV routes of administration, data from Part 1 (IV) and Part 2 (IM) were combined to enable an estimation of bioavailability of IM formulation.
Bioavailability of Sotrovimab was estimated using ANCOVA model with AUClast as dependent variable and ethnicity, body weight, route of administration as covariates with all available data (Part 1 \[IV\] and Part 2 \[IM\]) of Sotrovimab concentrations in serum. The AUClast Geometric Least Squares (LS) Means were estimated for each formulation and then a single parameter reported as the ratio of the AUClast geometric LS means (IM/IV) along with the 90% Confidence Interval were calculated. A single ratio parameter derived using the Geometric LS Means of AUClast IM versus IV and associated 90% Confidence Interval are presented.
Outcome measures
| Measure |
Part 1: Sotrovimab 500 mg IV (Japanese)
n=38 Participants
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1.
|
Part 1: Sotrovimab 500 mg IV (Japanese)
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
|---|---|---|---|---|
|
Part 1 and Part 2: Bioavailability of Sotrovimab IM Versus IV Formulation Using AUClast
|
0.5179 Ratio
Interval 0.4498 to 0.5964
|
—
|
—
|
—
|
Adverse Events
Part 1: Placebo IV (Japanese)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1:Placebo IV (Caucasian)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Sotrovimab 500 mg IV (Japanese)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Sotrovimab 500 mg IV (Caucasian)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Placebo IM (Japanese)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Placebo IM (Caucasian)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Sotrovimab 500 mg IM (Japanese)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: Sotrovimab 500 mg IM (Caucasian)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Placebo IV (Japanese)
n=3 participants at risk
Japanese participants received a volume-matched saline placebo (Sterile 0.9 percent \[%\] weight/volume \[w/v\] sodium chloride solution) matching intravenous (IV) infusion of sotrovimab on Day 1.
|
Part 1:Placebo IV (Caucasian)
n=3 participants at risk
Caucasian participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Japanese)
n=9 participants at risk
Japanese participants received a single 500 milligrams (mg) IV infusion of sotrovimab on Day 1
|
Part 1: Sotrovimab 500 mg IV (Caucasian)
n=9 participants at risk
Caucasian participants received a single 500 mg IV infusion of sotrovimab on Day 1
|
Part 2: Placebo IM (Japanese)
n=2 participants at risk
Japanese participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching intramuscular (IM) injection of sotrovimab on Day 1.
|
Part 2: Placebo IM (Caucasian)
n=2 participants at risk
Caucasian participants received a volume-matched saline placebo (Sterile 0.9% \[w/v\] sodium chloride solution) matching IM injection of sotrovimab on Day 1.
|
Part 2: Sotrovimab 500 mg IM (Japanese)
n=10 participants at risk
Japanese participants received a single 500 mg IM injection of sotrovimab (administered as two 4 milliliters \[mL\] injections, one in each dorsogluteal muscle) on Day 1.
|
Part 2: Sotrovimab 500 mg IM (Caucasian)
n=10 participants at risk
Caucasian participants received a single 500 mg IM injection of sotrovimab (administered as two 4 mL injections, one in each dorsogluteal muscle) on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
30.0%
3/10 • Number of events 3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
|
Vascular disorders
Vascular pain
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/2 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
0.00%
0/10 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to Week 18 in Parts 1 and 2 of the study
Safety Population was used to assess all-cause mortality, SAE and non-SAE which comprised of all randomized participants who were exposed to study intervention.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place