Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 (NCT NCT04779879)

Results Overview

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. A 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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

354 participants

Primary outcome timeframe

Up to Day 29

Results posted on

2023-05-03

Participant Flow

Randomized, parallel group study conducted in non-hospitalized participants with mild to moderate Coronavirus Disease 2019 (COVID-19) who received Sotrovimab (VIR-7831) Generation1 (Gen 1) and Gen2.

Total of 354 participants (30 participants in Part A, 167 participants in Part B, 157 participants in Part C) were enrolled in the study.

Participant milestones

Participant milestones
Measure	Part A-Sotrovimab Gen1: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Part B- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.	Part B- Sotrovimab Gen2: 500 mg IM Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.	Part C- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.	Part C- Sotrovimab Gen2: 250 mg IM Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
Part A: Up to Week 24 STARTED	8	22	0	0	0	0
Part A: Up to Week 24 Treatment Received	8	22	0	0	0	0
Part A: Up to Week 24 COMPLETED	8	22	0	0	0	0
Part A: Up to Week 24 NOT COMPLETED	0	0	0	0	0	0
Part B: Up to Week 36 STARTED	0	0	84	83	0	0
Part B: Up to Week 36 Treatment Received	0	0	84	82	0	0
Part B: Up to Week 36 COMPLETED	0	0	84	81	0	0
Part B: Up to Week 36 NOT COMPLETED	0	0	0	2	0	0
Part C: Up to Week 36 STARTED	0	0	0	0	79	78
Part C: Up to Week 36 Treatment Received	0	0	0	0	79	78
Part C: Up to Week 36 COMPLETED	0	0	0	0	75	75
Part C: Up to Week 36 NOT COMPLETED	0	0	0	0	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Part B- Sotrovimab Gen2: 500 mg IM Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.	Part C- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.	Part C- Sotrovimab Gen2: 250 mg IM Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
Part B: Up to Week 36 Randomized, but did not receive treatment	1	0	0
Part B: Up to Week 36 Withdrawal by Subject	1	0	0
Part C: Up to Week 36 Death	0	0	1
Part C: Up to Week 36 Withdrawal by Subject	0	4	2

Baseline Characteristics

Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Part B- Sotrovimab Gen2: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.	Part B- Sotrovimab Gen2: 500 mg IM n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.	Part C- Sotrovimab Gen2: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.	Part C- Sotrovimab Gen2: 250 mg IM n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.	Total n=353 Participants Total of all reporting groups
Age, Customized Participants · <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Age, Customized Participants · 19-64 years	8 Participants n=5 Participants	20 Participants n=7 Participants	80 Participants n=5 Participants	76 Participants n=4 Participants	77 Participants n=21 Participants	74 Participants n=10 Participants	335 Participants n=115 Participants
Age, Customized Participants · >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	16 Participants n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	45 Participants n=5 Participants	42 Participants n=4 Participants	39 Participants n=21 Participants	42 Participants n=10 Participants	183 Participants n=115 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	12 Participants n=7 Participants	39 Participants n=5 Participants	40 Participants n=4 Participants	40 Participants n=21 Participants	36 Participants n=10 Participants	170 Participants n=115 Participants
Race/Ethnicity, Customized Participants · Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants	9 Participants n=10 Participants	24 Participants n=115 Participants
Race/Ethnicity, Customized Participants · White - White/Caucasian/European Heritage	6 Participants n=5 Participants	21 Participants n=7 Participants	62 Participants n=5 Participants	64 Participants n=4 Participants	66 Participants n=21 Participants	63 Participants n=10 Participants	282 Participants n=115 Participants
Race/Ethnicity, Customized Participants · White - Arabic/North African Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=10 Participants	16 Participants n=115 Participants
Race/Ethnicity, Customized Participants · Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Race/Ethnicity, Customized Participants · Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	24 Participants n=115 Participants
Race/Ethnicity, Customized Participants · Asian - Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Participants · American Indian Or Alaska Native	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	1 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Participants · Mixed Asian Race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants

PRIMARY outcome

Timeframe: Up to Day 29

Population: Safety Population consisted 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. A 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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 All AEs	0 Participants	3 Participants	—
Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 SAEs	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 IRR including hypersensitivity	0 Participants	0 Participants	—
Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 Events related to antibody-dependent enhancement	0 Participants	0 Participants	—
Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 Events related to immunogenicity	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 Abnormal-Clinically significant	0 Participants	0 Participants	—
Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 Abnormal-Not Clinically significant	6 Participants	17 Participants	—

PRIMARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 1 to Day 8

Population: Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points without missing covariate information were analyzed.

AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal (NP) swab samples. Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=64 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=65 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8)	24.40 Day*log10 copies per (/) milliliter (mL) Interval 23.53 to 25.31	25.28 Day*log10 copies per (/) milliliter (mL) Interval 24.38 to 26.21	—

PRIMARY outcome

Timeframe: Day 1 to Day 8

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.

AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in NP swab samples. Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=55 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=62 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)	26.20 Day*log10 copies/mL Interval 24.68 to 27.81	26.72 Day*log10 copies/mL Interval 25.26 to 28.27	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: 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. Adverse events which were not Serious were considered as Non-Serious adverse events.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With Non-Serious AEs Through Week 12	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population.

A 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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With SAEs Through Week 24	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With AESI Through Week 24 IRR including hypersensitivity	0 Participants	0 Participants	—
Part A: Number of Participants With AESI Through Week 24 Events related to antibody-dependent enhancement	0 Participants	0 Participants	—
Part A: Number of Participants With AESI Through Week 24 Events related to immunogenicity	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Days 1, 5, 11 and 85 (Week 12)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 11:Abnormal-NCS,n=8,22	5 Participants	12 Participants	—
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 1: Abnormal-CS, n=7,22	0 Participants	0 Participants	—
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 1:Abnormal-NCS, n=7,22	4 Participants	13 Participants	—
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 5: Abnormal-CS, n=7,21	0 Participants	0 Participants	—
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 5:Abnormal-NCS, n=7,21	5 Participants	10 Participants	—
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 11: Abnormal-CS, n=8,22	0 Participants	0 Participants	—
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 85 (Week 12): Abnormal-CS, n=8,22	0 Participants	0 Participants	—
Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 85 (Week 12):Abnormal-NCS,n=8,22	6 Participants	10 Participants	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population.

AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: 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. A 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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With All AEs and SAEs Through Day 29 All AEs	8 Participants	17 Participants	—
Part B: Number of Participants With All AEs and SAEs Through Day 29 SAEs	1 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity; injection site reactions (ISRs); events related to antibody-dependent enhancement; events related to immunogenicity.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With AESI Through Day 29 Events related to immunogenicity	0 Participants	0 Participants	—
Part B: Number of Participants With AESI Through Day 29 IRR including hypersensitivity	0 Participants	1 Participants	—
Part B: Number of Participants With AESI Through Day 29 Injection site reactions	0 Participants	10 Participants	—
Part B: Number of Participants With AESI Through Day 29 Events related to antibody-dependent enhancement	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 Abnormal-Clinically significant	1 Participants	1 Participants	—
Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 Abnormal-Not Clinically significant	43 Participants	39 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29	0 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: 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. A 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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With All AEs and SAEs Through Day 29 All AEs	10 Participants	13 Participants	—
Part C: Number of Participants With All AEs and SAEs Through Day 29 SAEs	1 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With AESI Through Day 29 IRR including hypersensitivity	0 Participants	0 Participants	—
Part C: Number of Participants With AESI Through Day 29 Injection site reactions	0 Participants	4 Participants	—
Part C: Number of Participants With AESI Through Day 29 Events related to antibody-dependent enhancement	0 Participants	0 Participants	—
Part C: Number of Participants With AESI Through Day 29 Events related to immunogenicity	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 Abnormal-Clinically significant	0 Participants	0 Participants	—
Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 Abnormal-Not Clinically significant	38 Participants	37 Participants	—

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety Population.

AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With Non-Serious AEs Through Week 12	8 Participants	20 Participants	—

SECONDARY outcome

Timeframe: Up to Week 36

Population: Safety Population.

A 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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With SAEs Through Week 36	1 Participants	2 Participants	—

SECONDARY outcome

Timeframe: up to Week 36

Population: Safety Population.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With AESI Through Week 36 IRR including hypersensitivity reaction	0 Participants	1 Participants	—
Part B: Number of Participants With AESI Through Week 36 Injection site reactions	0 Participants	10 Participants	—
Part B: Number of Participants With AESI Through Week 36 Events related to antibody-dependent enhancement	0 Participants	0 Participants	—
Part B: Number of Participants With AESI Through Week 36 Events related to immunogenicity	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Days 1, 5, 11 and 85 (Week 12)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 1: Abnormal-CS, n=84,82	1 Participants	0 Participants	—
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 1:Abnormal-NCS, n=84,82	33 Participants	31 Participants	—
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 5: Abnormal-CS, n=80,78	0 Participants	1 Participants	—
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 5:Abnormal-NCS, n=80,78	28 Participants	24 Participants	—
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 11: Abnormal-CS, n=82,78	0 Participants	0 Participants	—
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 11:Abnormal-NCS,n=82,78	20 Participants	24 Participants	—
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 85 (Week 12): Abnormal-CS, n=78,79	0 Participants	0 Participants	—
Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 85 (Week 12):Abnormal-NCS,n=78,79	24 Participants	20 Participants	—

SECONDARY outcome

Timeframe: Up to Week 36

Population: Safety Population.

AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=84 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=82 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Number of Participants With Disease Progression Events Through Week 36	2 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With Non-Serious AEs Through Week 12	16 Participants	16 Participants	—

SECONDARY outcome

Timeframe: Up to Week 36

Population: Safety Population.

A 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, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With SAEs Through Week 36	2 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to Week 36

Population: Safety Population.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With AESI Through Week 36 IRR including hypersensitivity	0 Participants	0 Participants	—
Part C: Number of Participants With AESI Through Week 36 Injection site reactions	0 Participants	4 Participants	—
Part C: Number of Participants With AESI Through Week 36 Events related to antibody-dependent enhancement	0 Participants	0 Participants	—
Part C: Number of Participants With AESI Through Week 36 Events related to immunogenicity	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Days 1, 5, 11 and 85 (Week 12)

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 1: Abnormal-CS, n=79,78	0 Participants	0 Participants	—
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 1:Abnormal-NCS, n=79,78	29 Participants	28 Participants	—
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 5: Abnormal-CS, n=76,74	0 Participants	0 Participants	—
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 5:Abnormal-NCS, n=76,74	25 Participants	23 Participants	—
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 11: Abnormal-CS, n=72,76	0 Participants	0 Participants	—
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 11:Abnormal-NCS,n=72,76	21 Participants	23 Participants	—
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 85 (Week 12): Abnormal-CS, n=73,77	0 Participants	0 Participants	—
Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points Day 85 (Week 12):Abnormal-NCS,n=73,77	20 Participants	23 Participants	—

SECONDARY outcome

Timeframe: Up to Week 36

Population: Safety Population.

AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=79 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=78 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Number of Participants With Disease Progression Events Through Week 36	1 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Baseline, Days 2, 5, 8, 11, 15, 22 and 29

Population: Virology Population consisted of all participants in the Safety Population with a central lab confirmed quantifiable nasal mid-turbinate and/or saliva swab at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

SARS-CoV-2 viral load was based on saliva and nasal mid-turbinate swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the NEG and \<2.08 results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=6 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=16 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 2: Saliva, n=4,11	-0.270 Log10 copies/mL Standard Deviation 0.4290	-1.114 Log10 copies/mL Standard Deviation 0.9201	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 5: Saliva, n=3,11	-0.780 Log10 copies/mL Standard Deviation 0.3404	-2.620 Log10 copies/mL Standard Deviation 1.0199	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 8: Saliva, n=3,11	-0.507 Log10 copies/mL Standard Deviation 0.5689	-2.605 Log10 copies/mL Standard Deviation 1.4982	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 11: Saliva, n=4,10	-1.043 Log10 copies/mL Standard Deviation 0.5940	-2.881 Log10 copies/mL Standard Deviation 1.3963	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 15: Saliva, n=4,11	-0.610 Log10 copies/mL Standard Deviation 1.3444	-3.179 Log10 copies/mL Standard Deviation 1.2132	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 22: Saliva, n=4,11	-1.043 Log10 copies/mL Standard Deviation 0.5940	-3.284 Log10 copies/mL Standard Deviation 1.3210	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 29: Saliva, n=4,11	-1.043 Log10 copies/mL Standard Deviation 0.5940	-3.223 Log10 copies/mL Standard Deviation 1.3123	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 2: Nasal mid-turbinate, n=5,16	-1.252 Log10 copies/mL Standard Deviation 0.9726	-1.006 Log10 copies/mL Standard Deviation 1.2277	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 5: Nasal mid-turbinate, n=4,16	-1.755 Log10 copies/mL Standard Deviation 1.1230	-2.111 Log10 copies/mL Standard Deviation 1.2100	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 8: Nasal mid-turbinate, n=4,16	-1.705 Log10 copies/mL Standard Deviation 0.7839	-2.703 Log10 copies/mL Standard Deviation 1.7842	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 11: Nasal mid-turbinate, n=5,16	-2.810 Log10 copies/mL Standard Deviation 1.3363	-2.923 Log10 copies/mL Standard Deviation 1.5656	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 15: Nasal mid-turbinate, n=5,16	-2.490 Log10 copies/mL Standard Deviation 1.3243	-3.445 Log10 copies/mL Standard Deviation 1.7103	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 22: Nasal mid-turbinate, n=5,16	-2.668 Log10 copies/mL Standard Deviation 1.2826	-3.873 Log10 copies/mL Standard Deviation 1.9434	—
Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load Day 29: Nasal mid-turbinate, n=5,16	-2.810 Log10 copies/mL Standard Deviation 1.3363	-3.752 Log10 copies/mL Standard Deviation 1.8030	—

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29

Population: Viral Pharmacodynamic Population consisted of all participants in the Safety Population who had a Baseline (Day 1) quantifiable viral load as assessed using qRT-PCR from NP swabs. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "\<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=66 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=68 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 2: n=63,68	-1.146 Log10 copies/mL Standard Deviation 1.1558	-0.611 Log10 copies/mL Standard Deviation 1.1518	—
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 3: n=63,66	-1.438 Log10 copies/mL Standard Deviation 1.2033	-1.306 Log10 copies/mL Standard Deviation 1.3132	—
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 5: n=62,64	-2.578 Log10 copies/mL Standard Deviation 1.2480	-2.352 Log10 copies/mL Standard Deviation 1.1655	—
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 8: n=64,64	-3.069 Log10 copies/mL Standard Deviation 1.4553	-3.254 Log10 copies/mL Standard Deviation 1.4193	—
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 11: n=62,63	-3.522 Log10 copies/mL Standard Deviation 1.7148	-3.574 Log10 copies/mL Standard Deviation 1.4907	—
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 15: n=62,66	-3.705 Log10 copies/mL Standard Deviation 1.7443	-3.733 Log10 copies/mL Standard Deviation 1.5525	—
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 22: n=64,66	-3.831 Log10 copies/mL Standard Deviation 1.7994	-3.778 Log10 copies/mL Standard Deviation 1.7476	—
Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 29: n=62,64	-3.933 Log10 copies/mL Standard Deviation 1.8253	-3.857 Log10 copies/mL Standard Deviation 1.7455	—

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "\<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=61 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=66 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 2: n=59,64	-0.429 Log10 copies per milliliter Standard Deviation 1.3835	-0.519 Log10 copies per milliliter Standard Deviation 1.3273	—
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 3: n=50,57	-0.905 Log10 copies per milliliter Standard Deviation 1.5202	-1.123 Log10 copies per milliliter Standard Deviation 1.6172	—
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 5: n=57,62	-2.076 Log10 copies per milliliter Standard Deviation 1.9648	-1.967 Log10 copies per milliliter Standard Deviation 2.0218	—
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 8: n=55,62	-3.122 Log10 copies per milliliter Standard Deviation 1.8234	-3.180 Log10 copies per milliliter Standard Deviation 1.8324	—
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 11: n=52,61	-3.617 Log10 copies per milliliter Standard Deviation 1.6870	-3.738 Log10 copies per milliliter Standard Deviation 1.8168	—
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 15: n=50,61	-3.719 Log10 copies per milliliter Standard Deviation 1.8248	-3.836 Log10 copies per milliliter Standard Deviation 1.8148	—
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 22: n=55,65	-3.693 Log10 copies per milliliter Standard Deviation 1.7647	-3.956 Log10 copies per milliliter Standard Deviation 1.7492	—
Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples Day 29: n=56,63	-3.761 Log10 copies per milliliter Standard Deviation 1.8167	-3.963 Log10 copies per milliliter Standard Deviation 1.7189	—

SECONDARY outcome

Timeframe: Days 2, 3, 5, 8, 11, 15, 22 and 29

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=66 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=68 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Percentage of Participants With Undetectable Viral Load Day 2: n=63,68	10 Percentage of participants	4 Percentage of participants	—
Part B: Percentage of Participants With Undetectable Viral Load Day 3: n=63,66	11 Percentage of participants	9 Percentage of participants	—
Part B: Percentage of Participants With Undetectable Viral Load Day 5: n=62,64	23 Percentage of participants	27 Percentage of participants	—
Part B: Percentage of Participants With Undetectable Viral Load Day 8: n=64,64	34 Percentage of participants	38 Percentage of participants	—
Part B: Percentage of Participants With Undetectable Viral Load Day 11: n=62,63	58 Percentage of participants	51 Percentage of participants	—
Part B: Percentage of Participants With Undetectable Viral Load Day 15: n=62,66	61 Percentage of participants	73 Percentage of participants	—
Part B: Percentage of Participants With Undetectable Viral Load Day 22: n=64,66	73 Percentage of participants	74 Percentage of participants	—
Part B: Percentage of Participants With Undetectable Viral Load Day 29: n=62,64	81 Percentage of participants	84 Percentage of participants	—

SECONDARY outcome

Timeframe: Days 2, 3, 5, 8, 11, 15, 22 and 29

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=61 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=66 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Percentage of Participants With Undetectable Viral Load Day 11: n=52,61	63 Percentage of participants	72 Percentage of participants	—
Part C: Percentage of Participants With Undetectable Viral Load Day 15: n=50,61	82 Percentage of participants	80 Percentage of participants	—
Part C: Percentage of Participants With Undetectable Viral Load Day 22: n=55,65	80 Percentage of participants	88 Percentage of participants	—
Part C: Percentage of Participants With Undetectable Viral Load Day 29: n=56,63	88 Percentage of participants	86 Percentage of participants	—
Part C: Percentage of Participants With Undetectable Viral Load Day 2: n=59,64	10 Percentage of participants	5 Percentage of participants	—
Part C: Percentage of Participants With Undetectable Viral Load Day 3: n=50,57	10 Percentage of participants	14 Percentage of participants	—
Part C: Percentage of Participants With Undetectable Viral Load Day 5: n=57,62	28 Percentage of participants	16 Percentage of participants	—
Part C: Percentage of Participants With Undetectable Viral Load Day 8: n=55,62	42 Percentage of participants	39 Percentage of participants	—

SECONDARY outcome

Timeframe: Day 1 to Day 5

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.

AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=63 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=65 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)	16.14 Day*log10 copies/mL Interval 15.53 to 16.77	16.97 Day*log10 copies/mL Interval 16.34 to 17.62	—

SECONDARY outcome

Timeframe: Day 1 to Day 11

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.

AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=64 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=65 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)	31.69 Day*log10 copies/mL Interval 30.6 to 32.82	32.39 Day*log10 copies/mL Interval 31.28 to 33.53	—

SECONDARY outcome

Timeframe: Day 1 to Day 5

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.

AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=57 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=63 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)	17.42 Day*log10 copies/mL Interval 16.49 to 18.41	17.56 Day*log10 copies/mL Interval 16.66 to 18.51	—

SECONDARY outcome

Timeframe: Day 1 to Day 11

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points without missing covariate information were analyzed.

AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=53 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=62 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)	33.02 Day*log10 copies/mL Interval 31.17 to 34.97	33.63 Day*log10 copies/mL Interval 31.89 to 35.47	—

SECONDARY outcome

Timeframe: Day 8

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.

Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=64 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=64 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 >=4.1 log 10 copies/mL	17 Percentage of participants	11 Percentage of participants	—
Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 <4.1 log 10 copies/mL	83 Percentage of participants	89 Percentage of participants	—

SECONDARY outcome

Timeframe: Day 8

Population: Viral Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed.

Percentage of participants with a persistently high viral load were categorized as \>=4.1 log10 copies/mL and \<4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=55 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=62 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 >=4.1 log 10 copies/mL	15 Percentage of participants	13 Percentage of participants	—
Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 <4.1 log 10 copies/mL	85 Percentage of participants	87 Percentage of participants	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values). Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration	147.1 Microgram per mL Standard Deviation 48.28	204.7 Microgram per mL Standard Deviation 77.61	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=6 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Cmax of VIR-7831 After IV Administration	156.5 Microgram per mL Standard Deviation 40.80	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Cmax of VIR-7831 After IM Administration	28.8 Microgram per mL Standard Deviation 15.66	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=5 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Cmax of VIR-7831 After IV Administration	137.4 Microgram per mL Standard Deviation 32.97	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Cmax of VIR-7831 After IM Administration	11.1 Microgram per mL Standard Deviation 5.61	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration	6.9 Microgram per mL Standard Deviation 2.16	8.1 Microgram per mL Standard Deviation 2.17	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Clast of VIR-7831 After IV Administration	7.0 Microgram per mL Standard Deviation 2.48	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Clast of VIR-7831 After IM Administration	7.9 Microgram per mL Standard Deviation 7.65	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Clast of VIR-7831 After IV Administration	10.5 Microgram per mL Standard Deviation 12.59	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Clast of VIR-7831 After IM Administration	2.6 Microgram per mL Standard Deviation 1.73	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration	0.042 Day Interval 0.04 to 0.38	0.042 Day Interval 0.04 to 0.38	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=6 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Tmax of VIR-7831 After IV Administration	0.026 Day Interval 0.01 to 0.03	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Tmax of VIR-7831 After IM Administration	6.878 Day Interval 3.68 to 56.66	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=5 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Tmax of VIR-7831 After IV Administration	0.014 Day Interval 0.01 to 0.02	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Tmax of VIR-7831 After IM Administration	27.866 Day Interval 13.88 to 56.04	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. The time frame is beyond Day 169 as there was one PK sample collected outside of the protocol defined window of +/- 7 days that was included in the analysis (PK sample collected up to Day 169 +/- 12 days).

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration	161.333 Day Interval 160.89 to 174.95	162.248 Day Interval 160.7 to 180.15	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Tlast of VIR-7831 After IV Administration	167.715 Day Interval 160.76 to 175.68	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. The upper value of the full range is outside of the time frame due to the protocol defined time point of Day 169+/-7 days.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Tlast of VIR-7831 After IM Administration	167.670 Day Interval 55.68 to 175.66	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Tlast of VIR-7831 After IV Administration	162.458 Day Interval 27.79 to 185.75	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. The time frame is beyond Day 169 as there were a few PK samples collected outside of the protocol defined window of +/- 7 days that were included in the analysis (PK samples collected up to Day 169 +/- 18 days).

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Tlast of VIR-7831 After IM Administration	168.912 Day Interval 160.97 to 180.83	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration	1355.2 Day*microgram/mL Standard Deviation 392.56	1738.8 Day*microgram/mL Standard Deviation 308.31	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: AUCD1-29 of VIR-7831 After IV Administration	1442.9 Day*microgram/mL Standard Deviation 296.96	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: AUCD1-29 of VIR-7831 After IM Administration	686.9 Day*microgram/mL Standard Deviation 376.78	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: AUCD1-29 of VIR-7831 After IV Administration	1405.4 Day*microgram/mL Standard Deviation 528.26	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: AUCD1-29 of VIR-7831 After IM Administration	327.1 Day*microgram/mL Standard Deviation 242.84	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=21 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration	3982.7 Day*microgram/mL Standard Deviation 1289.19	5238.4 Day*microgram/mL Standard Deviation 966.33	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: AUC(0-inf) of VIR-7831 After IV Administration	4449.3 Day*microgram/mL Standard Deviation 1123.41	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: AUC(0-inf) of VIR-7831 After IM Administration	3194.4 Day*microgram/mL Standard Deviation 1617.36	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=9 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: AUC(0-inf) of VIR-7831 After IV Administration	4255.3 Day*microgram/mL Standard Deviation 1369.36	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: AUC(0-inf) of VIR-7831 After IM Administration	1441.0 Day*microgram/mL Standard Deviation 985.65	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration	3456.5 Day*microgram/mL Standard Deviation 1086.56	4528.5 Day*microgram/mL Standard Deviation 826.89	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: AUClast of VIR-7831 After IV Administration	3848.5 Day*microgram/mL Standard Deviation 899.51	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: AUClast of VIR-7831 After IM Administration	2446.5 Day*microgram/mL Standard Deviation 1249.20	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: AUClast of VIR-7831 After IV Administration	3492.6 Day*microgram/mL Standard Deviation 1257.27	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: AUClast of VIR-7831 After IM Administration	1185.8 Day*microgram/mL Standard Deviation 763.78	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=21 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration	14.9 Percentage of AUCexp Standard Deviation 2.81	12.6 Percentage of AUCexp Standard Deviation 3.42	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: %AUCexp of VIR-7831 After IV Administration	13.1 Percentage of AUCexp Standard Deviation 2.92	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: %AUCexp of VIR-7831 After IM Administration	15.0 Percentage of AUCexp Standard Deviation 2.35	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=9 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: %AUCexp of VIR-7831 After IV Administration	13.6 Percentage of AUCexp Standard Deviation 4.29	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: %AUCexp of VIR-7831 After IM Administration	15.0 Percentage of AUCexp Standard Deviation 2.11	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=21 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration	63.196 Day Interval 53.98 to 68.09	55.547 Day Interval 42.34 to 72.09	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: t1/2 of VIR-7831 After IV Administration	55.735 Day Interval 47.33 to 66.86	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: t1/2 of VIR-7831 After IM Administration	59.347 Day Interval 51.95 to 65.83	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=9 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: t1/2 of VIR-7831 After IV Administration	60.938 Day Interval 42.96 to 70.84	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: t1/2 of VIR-7831 After IM Administration	61.867 Day Interval 46.84 to 68.43	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=21 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831	12.40 Liter Standard Deviation 4.625	7.88 Liter Standard Deviation 1.374	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Vz of VIR-7831 After IV Administration	9.97 Liter Standard Deviation 2.865	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration	18.14 Liter Standard Deviation 12.752	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=9 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Vz of VIR-7831 After IV Administration	10.93 Liter Standard Deviation 3.574	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Vz/F of VIR-7831 After IM Administration	20.24 Liter Standard Deviation 10.205	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=21 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration	11.42 Liter Standard Deviation 4.110	7.47 Liter Standard Deviation 1.232	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Vss of VIR-7831 After IV Administration	9.41 Liter Standard Deviation 2.514	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=9 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: Vss of VIR-7831 After IV Administration	10.61 Liter Standard Deviation 3.973	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=21 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part A: Clearance (CL) of VIR-7831 After IV Administration	136.8 Milliliter per day Standard Deviation 42.88	98.7 Milliliter per day Standard Deviation 18.62	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: CL of VIR-7831 After IV Administration	120.3 Milliliter per day Standard Deviation 35.96	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration	216.2 Milliliter per day Standard Deviation 162.28	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=9 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: CL of VIR-7831 After IV Administration	130.5 Milliliter per day Standard Deviation 47.83	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Part C: CL/F of VIR-7831 After IM Administration	237.8 Milliliter per day Standard Deviation 125.67	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Data from Parts B and C is presented in a single outcome to determine the absolute bioavailability (F) based on the loge transformed dose normalized AUCinf for the IV (500 mg), IM (500 mg), and IM (250 mg). Data for 500 mg IV arms with similar dosing strategies across Parts B and C is combined as pre-specified in reporting and analysis plan.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Dose-normalized least square geometric mean ratio of AUCinf was derived based on collected assessments up to 169 (+/-7 days) for Part B- Sotrovimab Gen2: 500 mg IV arm, and up to 169 (+/-18 days) for Part C- Sotrovimab Gen2: 500 mg IV arm.

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) n=20 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Three Dose Levels (250 mg IM in Part C, 500 mg IM in Part B and 500 mg IV in Parts B and C)	5.52 Day*microgram/mL Interval 4.25 to 7.16	4.86 Day*microgram/mL Interval 3.75 to 6.3	8.40 Day*microgram/mL Interval 7.12 to 9.9

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=8 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)	5.56 Day*microgram per milliliter Interval 3.81 to 8.11	4.86 Day*microgram per milliliter Interval 3.33 to 7.09	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Dose-normalized Least Square Geometric Mean Ratio of AUClast for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)	4.31 Day*microgram per milliliter Interval 3.21 to 5.77	4.05 Day*microgram per milliliter Interval 2.98 to 5.51	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=10 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Dose-normalized Least Square Geometric Mean Ratio of AUCD1-D29 for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)	1.17 Day*microgram per milliliter Interval 0.83 to 1.65	1.06 Day*microgram per milliliter Interval 0.74 to 1.51	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

Outcome measures

Outcome measures
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=11 Participants Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=7 Participants Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Sotrovimab Gen2: 500 mg IV (Parts B and C) Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Parts B and C.
Dose-normalized Least Square Geometric Mean Ratio of Cmax for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)	0.05 Microgram per milliliter Interval 0.04 to 0.07	0.04 Microgram per milliliter Interval 0.03 to 0.06	—

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 participants at risk Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Part B- Sotrovimab Gen2: 500 mg IV n=84 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.	Part B- Sotrovimab Gen2: 500 mg IM n=82 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.	Part C- Sotrovimab Gen2: 500 mg IV n=79 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.	Part C- Sotrovimab Gen2: 250 mg IM n=78 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
Infections and infestations COVID-19 pneumonia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	3.8% 3/78 • Number of events 3 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Coronavirus pneumonia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Pneumonia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.

Other adverse events

Other adverse events
Measure	Part A-Sotrovimab Gen1: 500 mg IV n=8 participants at risk Participants received Sotrovimab (VIR-7831) Gen1 500 milligrams (mg) intravenous (IV) infusion on Day 1 in Part A.	Part A- Sotrovimab Gen2: 500 mg IV n=22 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part A.	Part B- Sotrovimab Gen2: 500 mg IV n=84 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part B.	Part B- Sotrovimab Gen2: 500 mg IM n=82 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg intramuscular (IM) injection on Day 1 in Part B.	Part C- Sotrovimab Gen2: 500 mg IV n=79 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 500 mg IV infusion on Day 1 in Part C.	Part C- Sotrovimab Gen2: 250 mg IM n=78 participants at risk Participants received Sotrovimab (VIR-7831) Gen2 250 mg IM injection on Day 1 in Part C.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Blood and lymphatic system disorders Iron deficiency anemia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Ear and labyrinth disorders Motion sickness	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Ear and labyrinth disorders vertigo	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Eye disorders Episcleritis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Nausea	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.5% 2/79 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Paraesthesia Oral	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Uvulitis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
General disorders Feeling abnormal	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
General disorders Influenza like illness	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
General disorders Injection site discomfort	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
General disorders Injection site nodule	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
General disorders Injection site pain	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	12.2% 10/82 • Number of events 13 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.6% 2/78 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
General disorders Peripheral swelling	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Acute sinusitis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Blister infected	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Cellulitis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Conjunctivitis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Folliculitis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.5% 2/79 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Helicobacter gastritis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Herpes simplex	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Herpes zoster	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Nasopharyngitis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	3.8% 3/79 • Number of events 3 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Otitis media acute	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Pharyngitis streptococcal	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Sinusitis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.6% 2/78 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	3.8% 3/78 • Number of events 3 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Infections and infestations Urinary tract infection	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Injury, poisoning and procedural complications Limb injury	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.5% 2/79 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Investigations Brain natriuretic peptide increased	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Investigations Hepatic enzyme increased	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Investigations Lipase increased	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Metabolism and nutrition disorders Gout	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	4.5% 1/22 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.4% 2/82 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Nervous system disorders Dizziness	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Nervous system disorders Headache	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Nervous system disorders Migraine	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 3 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Nervous system disorders Restless legs syndrome	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.4% 2/84 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Psychiatric disorders Anxiety	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Psychiatric disorders Conversion disorder	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Psychiatric disorders Depression	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Psychiatric disorders Insomnia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Renal and urinary disorders Nephrolithiasis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.5% 2/79 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/82 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/78 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Vascular disorders Haematoma	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.2% 1/84 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/79 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Vascular disorders Hypertension	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	2.4% 2/82 • Number of events 2 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.
Vascular disorders Superficial vein thrombosis	0.00% 0/8 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/22 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/84 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/82 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	1.3% 1/79 • Number of events 1 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.	0.00% 0/78 • All-cause mortality, non-serious AEs and SAEs were collected up to Week 24 in Part A; and up to Week 36 in Parts B and C of the study Safety Population consisted of all randomized participants who were exposed to study intervention.

Additional Information

Study Inquiry

Vir Biotechnology, Inc.

Phone: 415-654-5281

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place