Relative Bioavailability, Safety, and Tolerability of Sin... | NCT05280717

ID	Type	Description	Link
GSK Study 218128	Other Identifier	GlaxoSmithKline

Name	Class
GlaxoSmithKline	INDUSTRY

Relative Bioavailability, Safety, and Tolerability of Sin... | NCT05280717 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A: Treatment arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Experimental	Participants will receive a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered via two injections intramuscularly into the dorsogluteal muscle on Day 1.	Biological: sotrovimab
Part A: Treatment arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)	Experimental	Participants will receive a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	Biological: sotrovimab
Part A: Treatment arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)	Experimental	Participants will receive a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.	Biological: sotrovimab
Part A: Treatment arm 4- Sotrovimab 100 mg/mL (Deltoid)	Experimental	Participants will receive a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	Biological: sotrovimab
Part B: Sotrovimab	Experimental	Participants will receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.

Name	Type	Description	Arm Group Labels	Other Names
sotrovimab	Biological	via IM injection	Part A: Treatment arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A (Treatment Arms 1 and 2): Area Under the Serum Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC[D1 to 29]) Following Administration of Sotrovimab	Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis.	Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Part A (Treatment Arms 1 and 2): Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab	Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.	Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Part A (Treatment Arms 1 and 2): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) Through Day 29	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.	Up to Day 29
Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29

Secondary Outcomes

Measure	Description	Time Frame
Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab	Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.	Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants, aged 18 to 65 years, inclusive.
Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
For Part C, inclusion in the Japanese subgroup analysis, a participant must meet all of the following criteria: Japanese ancestry, defined as being a descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents.
Body Mass Index (BMI) within the range of 18 to 30 kilogram per square meter (kg/m^2).
Capable of giving signed informed consent

Exclusion Criteria:

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Breast cancer within the past 10 years
Abnormal blood pressure at Screening.
Known hypersensitivity to any constituent present in the investigational product or history of severe hypersensitivity or anaphylaxis after receiving a COVID-19 vaccine
Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Use of any over the counter or prescription medications unless permitted by the protocol or approved by the Investigator in conjunction with the GSK medical monitor.
For Part A and Part B, any condition that would prohibit receipt of injections in the investigator's opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia.
Treatment with biologic agents (such as) within 3 months or 5 half-lives
Receipt of convalescent plasma from a recovered COVID-19 participant or anti- severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) monoclonal antibody (mAb) within the last 3 months.
Receipt of any vaccine within 48 hours prior to enrollment.
Has received a SARS-CoV-2 vaccine but has not completed all doses in the series more than 28 days prior to Screening.
Exposure to more than 4 new chemical entities (e.g., investigational pharmaceuticals) within 12 months prior to the first dosing day.
Enrolment in any investigational vaccine study within the last 180 days or enrollment in any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives
Current enrolment or past participation in this clinical study.
A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to dosing.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
History of regular alcohol consumption within 6 months prior to the study.
Regular use of known drugs of abuse.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Investigative Site		Riverside	California	92503	United States
Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41324898	Derived	Sanchez-Pearson Y, Moore J, Daniluk J, Bhangu S, Parra S, El Zailik A, Sarkar P, Aylott A, Moyo F, Peppercorn A, Skingsley A. Safety, Tolerability and Pharmacokinetics of a High-Dose, Rapid-Infusion Monoclonal Antibody: Phase I Results for Intravenous Sotrovimab 3000 mg. Drugs R D. 2025 Dec;25(4):367-376. doi: 10.1007/s40268-025-00530-9. Epub 2025 Dec 1.
39881564

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
FG001	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 30, 2023	Apr 4, 2024

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0013 subjects FG0022 subjects FG0030 subjects FG0040 subjects FG0050 subjects FG0060 subjects
Randomized but not received treatment		FG0001 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Participant was randomized for treatment arm 2 but dosed in treatment arm 4		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects
Participant was randomized for treatment arm 3 but dosed in treatment arm 4		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects

Part B (Up to Week 35)

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0050 subjects FG0060 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Part C (Up to Week 35)

Type	Comment	Milestone Data
STARTED	Enrolled	FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG005100 subjects FG0060 subjects
Safety Population		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Withdrawal by Subject		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
BG001	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.
BG002	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.
BG003	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
BG004	Part B: Sotrovimab	Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.
BG005	Part C: Cohort 1-Sotrovimab	Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
BG006	Part C: Cohort 2-Sotrovimab	Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.
BG007	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00042 BG00139 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Part A (Treatment Arms 1 and 2): Area Under the Serum Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC[D1 to 29]) Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis.

PK Population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment - i.e., PK sample collected and analyzed. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Mean

95% Confidence Interval

Day*microgram per milliliter

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.

Units	Counts
Participants	OG00065 OG00168

Title

Denominators

Categories

Title	Measurements
	OG000944.94(844.74 to 1057.02) OG001950.67(837.05 to 1079.72)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Ratio of geometric least square mean	0.9821			2-Sided	90	0.8825	1.0930			The ratio estimate and 90% confidence interval were obtained from an Analysis of covariance (ANCOVA) model, with AUC(D1- 29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.		Other

Primary

Part A (Treatment Arms 1 and 2): Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Mean

95% Confidence Interval

Microgram per milliliter

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001	Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.

Units	Counts
Participants

Primary

Part A (Treatment Arms 1 and 2): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Common (>=5%) Non-serious Adverse Events (Non-SAEs) Through Day 29

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Safety Population consisted of all randomized participants who were exposed to study intervention.

Posted

Count of Participants

Participants

Up to Day 29

ID	Title	Description
OG000	Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001

Primary

Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESI included hypersensitivity reaction based on a predefined list of terms.

Safety Population. Data was not collected as no participants were enrolled in Part C: Cohort 2.

Posted

Count of Participants

Participants

Up to Day 29

ID	Title	Description
OG000	Part C: Cohort 1-Sotrovimab	Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
OG001	Part C: Cohort 2-Sotrovimab	Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.

Secondary

Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Mean

95% Confidence Interval

Day*microgram per milliliter

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.
OG002	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.

Secondary

Part A (Treatment Arms 1, 3 and 4): Cmax Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Mean

95% Confidence Interval

Microgram per milliliter

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.
OG002	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.

Secondary

Part B: AUC(D1-29) Following Administration of Sotrovimab

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

PK Population. Data was not collected as no participants were enrolled in Part B.

Posted

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part B: Sotrovimab	Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.

Units	Counts
Participants	OG0000

Secondary

Part B: Cmax Following Administration of Sotrovimab

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

PK Population. Data was not collected as no participants were enrolled in Part B.

Posted

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part B: Sotrovimab	Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.

Units	Counts
Participants	OG0000

Secondary

Part C (Cohorts 1 and 2): AUC(D1-29) Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1. PK parameters were calculated using standard non-compartmental analysis.

PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Data was not collected as no participants were enrolled in Part C: Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part C: Cohort 1-Sotrovimab	Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
OG001	Part C: Cohort 2-Sotrovimab	Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.

Units	Counts
Participants

Secondary

Part C (Cohorts 1 and 2): Cmax Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1. PK parameters were calculated using standard non-compartmental analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram per milliliter

Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

ID	Title	Description
OG000	Part C: Cohort 1-Sotrovimab	Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
OG001	Part C: Cohort 2-Sotrovimab	Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.

Units	Counts
Participants

Secondary

Part A (Treatment Arms 1, 2, 3 and 4): Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) Following Administration of Sotrovimab at 3 Injection Sites

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 (Week 24) post-dose

ID	Title	Description
OG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.
OG002	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)

Secondary

Part B: AUCinf Following Administration of Sotrovimab at up to 2 Injection Sites

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

PK Population. Data was not collected as no participants were enrolled in Part B.

Posted

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 (Week 24) post-dose

ID	Title	Description
OG000	Part B: Sotrovimab	Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.

Units	Counts
Participants	OG000

Secondary

Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab.

PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Mean

Standard Deviation

Microgram per milliliter

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

ID	Title	Description
OG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.
OG002	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.

Secondary

Part B: Serum Concentration Following Administration of Sotrovimab

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

PK Population. Data was not collected as no participants were enrolled in Part B.

Posted

Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

ID	Title	Description
OG000	Part B: Sotrovimab	Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.

Units	Counts
Participants	OG0000

Secondary

Part C: Serum Concentration Following Administration of Sotrovimab

Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1.

Posted

Mean

Standard Deviation

Microgram per milliliter

Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

ID	Title	Description
OG000	Part C: Cohort 1-Sotrovimab	Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
OG001	Part C: Cohort 2-Sotrovimab	Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.

Units	Counts
Participants

Secondary

Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Safety Population.

Posted

Count of Participants

Participants

Up to Day 29 and Up to Week 35

ID	Title	Description
OG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.
OG001	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)

Secondary

Part B: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 and Week 35

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence 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. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Safety Population. Data was not collected as no participants were enrolled in Part B.

Posted

Up to Day 29 and Up to Week 35

ID	Title	Description
OG000	Part B: Sotrovimab	Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.

Units	Counts
Participants	OG000

Secondary

Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

Safety Population. Data was not collected as no participants were enrolled in Part C: Cohort 2.

Posted

Count of Participants

Participants

Up to Week 35

ID	Title	Description
OG000	Part C: Cohort 1-Sotrovimab	Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
OG001	Part C: Cohort 2-Sotrovimab	Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)	Participants received a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered two injections intramuscularly into the dorsogluteal muscle on Day 1.	71	1	71	29	71
EG001	Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.	71	1	71	22	71
EG002	Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.	35	0	35	13	35
EG003	Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid)	Participants received a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.	38	0	38	20	38
EG004	Part B: Sotrovimab	Participants were planned to receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.	0	0	0	0	0
EG005	Part C: Cohort 1-Sotrovimab	Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.	98	0	98	9	98
EG006	Part C: Cohort 2-Sotrovimab	Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.	0	0	0	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected71 at risk EG0011 affected71 at risk EG0020 affected35 at risk EG0030 affected38 at risk EG004
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 affected71 at risk EG0010 affected71 at risk EG0020 affected35 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected71 at risk EG0011 affected71 at risk EG0020 affected35 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected71 at risk EG0011 affected71 at risk EG0020 affected35 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG00025 affected71 at risk EG00114 affected71 at risk EG0029 affected35 at risk EG00318 affected38 at risk EG0040 affected0 at risk EG0050 affected98 at risk EG0060 affected0 at risk
Injection site induration	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected71 at risk EG0012 affected71 at risk EG0024 affected35 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 affected71 at risk EG0014 affected71 at risk EG0020 affected35 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected71 at risk EG0010 affected71 at risk EG0022 affected35 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected35 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected71 at risk EG0016 affected71 at risk EG0021 affected35 at risk EG003

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Ratio of geometric least square mean	1.1258			2-Sided	90	1.0108	1.2539			The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.		Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Ratio of geometric least square mean	1.8760			2-Sided	90	1.6391	2.1472			The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.		Other
OG000 OG002						Ratio of geometric least square mean	1.5991			2-Sided	90	1.4086	1.8153			The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.		Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Ratio of geometric least square mean	2.0798			2-Sided	90	1.8223	2.3737			The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.		Other
OG000 OG002						Ratio of geometric least square mean	1.6955			2-Sided	90	1.4913	1.9276			The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.		Other

Group IDs	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Ratio of geometric least square mean	0.9476	2-Sided	90	0.8578	1.0469	The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.	Other
OG000 OG002	Ratio of geometric least square mean	1.5482	2-Sided	90	1.3770	1.7407	The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.	Other
OG000 OG003	Ratio of geometric least square mean	1.4167	2-Sided	90	1.2627	1.5894	The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.	Other

Title

Denominators

Categories

Day 1: Pre-dose

- ParticipantsOG00071
- ParticipantsOG00169
- ParticipantsOG00234
- ParticipantsOG00338

Title

Measurements

OG0000.0± NAStandard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed).
OG0010.0± NAStandard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed).
OG0020.0± NAStandard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than \[\>\] 30 percent \[%\] of values were imputed).

Day 1: 1 hour

- ParticipantsOG00061
- ParticipantsOG00160
- ParticipantsOG00227
- ParticipantsOG00338

Day 1: 2 hours

- ParticipantsOG00071
- ParticipantsOG00169
- ParticipantsOG00235
- ParticipantsOG00337

Day 1: 6 hours

- ParticipantsOG00070
- ParticipantsOG00170
- ParticipantsOG00235
- ParticipantsOG00338

Day 1: 8 hours

- ParticipantsOG00071
- ParticipantsOG00170
- ParticipantsOG00235
- ParticipantsOG00338

Day 2

- ParticipantsOG00071
- ParticipantsOG00170
- ParticipantsOG00235
- ParticipantsOG00338

Day 3

- ParticipantsOG00071
- ParticipantsOG00170
- ParticipantsOG00235
- ParticipantsOG00338

Day 5

- ParticipantsOG00071
- ParticipantsOG00170
- ParticipantsOG00234
- ParticipantsOG00338

Day 8

- ParticipantsOG00070
- ParticipantsOG00170
- ParticipantsOG00235
- ParticipantsOG00338

Day 15

- ParticipantsOG00070
- ParticipantsOG00170
- ParticipantsOG00233
- ParticipantsOG00338

Day 29

- ParticipantsOG00070
- ParticipantsOG00169
- ParticipantsOG00233
- ParticipantsOG00338

Day 57

- ParticipantsOG00071
- ParticipantsOG00169
- ParticipantsOG00233
- ParticipantsOG00338

Day 85

- ParticipantsOG00070
- ParticipantsOG00168
- ParticipantsOG00233
- ParticipantsOG00338

Day 140

- ParticipantsOG00070
- ParticipantsOG00168
- ParticipantsOG00233
- ParticipantsOG00338

Day 168

- ParticipantsOG00069
- ParticipantsOG00168
- ParticipantsOG00233
- ParticipantsOG00338

Title

Denominators

Categories

Day 1: Pre-dose

- ParticipantsOG00087
- ParticipantsOG0010

Title	Measurements
	OG0000.0± NAStandard deviation could not be calculated due to high proportion of NQ values (\>30% of values were imputed).

Day 1: End of infusion

- ParticipantsOG00087
- ParticipantsOG0010

Title	Measurements
	OG0001069.2± 261.39

Day 1: 1 hour

- ParticipantsOG00098
- ParticipantsOG0010

Title	Measurements
	OG000976.3± 265.40

Day 1: 2 hours

- ParticipantsOG00098
- ParticipantsOG0010

Title	Measurements
	OG000993.3± 241.85

Day 1: 6 hours

- ParticipantsOG00098
- ParticipantsOG0010

Title	Measurements
	OG000921.5± 235.27

Day 1: 8 hours

- ParticipantsOG00098
- ParticipantsOG0010

Title	Measurements
	OG000934.3± 224.54

Day 2

- ParticipantsOG00096
- ParticipantsOG0010

Title	Measurements
	OG000802.9± 193.80

Day 3

- ParticipantsOG00097
- ParticipantsOG0010

Title	Measurements
	OG000685.1± 168.11

Day 5

- ParticipantsOG00098
- ParticipantsOG0010

Title	Measurements
	OG000584.8± 149.55

Day 8

- ParticipantsOG00098
- ParticipantsOG0010

Title	Measurements
	OG000470.9± 110.32

Day 15

- ParticipantsOG00097
- ParticipantsOG0010

Title	Measurements
	OG000407.4± 104.25

Day 29

- ParticipantsOG00098
- ParticipantsOG0010

Title	Measurements
	OG000320.2± 74.93

Day 57

- ParticipantsOG00085
- ParticipantsOG0010

Title	Measurements
	OG000223.9± 71.55

Day 85

- ParticipantsOG00085
- ParticipantsOG0010

Title	Measurements
	OG000159.1± 56.97

Day 140

- ParticipantsOG00095
- ParticipantsOG0010

Title	Measurements
	OG00085.9± 32.60

Day 168

- ParticipantsOG00096
- ParticipantsOG0010

Title	Measurements
	OG00061.0± 30.72

Title

Denominators

Categories

Up to Day 29: SAEs

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Up to Day 29: Non-SAEs

Title	Measurements
	OG00027 OG00120 OG00213 OG003

Up to Day 29: AESIs

Title	Measurements
	OG00024 OG00115 OG00213 OG003

Up to Week 35: SAEs

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Up to Week 35: Non-SAEs

Title	Measurements
	OG00029 OG00122 OG00213 OG003

Up to Week 35: AESIs

Title	Measurements
	OG00025 OG00115 OG00213 OG003