Covid19
Conditions
Keywords
COVID-19, Pharmacokinetics, Safety, Sotrovimab, Relative bioavailability, Healthy participants
Brief summary
This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years. The study will be conducted in three parts (Part A, an optional Part B and Part C). Part B and Part C (cohort 2) were optional so they were not initiated. Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
Interventions
BIOLOGICALsotrovimab
via IM injection
Sponsors
GlaxoSmithKline
Vir Biotechnology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis. |
| Part A (Treatment Arms 1 and 2): Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab | Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis. |
| 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 | Up to 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. |
| Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 | Up to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part C (Cohorts 1 and 2): AUC(D1-29) Following Administration of Sotrovimab | 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 | 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. |
| Part C (Cohorts 1 and 2): Cmax Following Administration of Sotrovimab | 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 | 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. |
| 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 | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: AUCinf Following Administration of Sotrovimab at up to 2 Injection Sites | 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 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab. |
| Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. |
| Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab | Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis. |
| Part C: Serum Concentration Following Administration of Sotrovimab | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1. |
| 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 | Up to Day 29 and Up to 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. |
| Part B: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 and Week 35 | Up to Day 29 and Up to 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. |
| Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35 | Up to 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. |
| Part B: Serum Concentration Following Administration of Sotrovimab | 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 | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab. |
| Part A (Treatment Arms 1, 3 and 4): Cmax Following Administration of Sotrovimab | Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: AUC(D1-29) Following Administration of Sotrovimab | Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab. |
| Part B: Cmax Following Administration of Sotrovimab | Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab. |
Countries
United States
Participant flow
Recruitment details
This was a 3-part (Parts A, B and C) study. A total of 316 participants (216 participants in Part A and 100 participants in Part C) were enrolled in this study. Three participants were enrolled but not dosed. A total of 313 participants (215 in Part A and 98 in Part C) received Sotrovimab creating Safety Population (Safety Population consisted of all randomized participants who were exposed to study intervention).
Pre-assignment details
Part B was optional and was not initiated in alignment with the strategic direction of the sotrovimab program and Part C Cohort-2 was optional and was not conducted as Part C Cohort-1 was stopped for programmatic reasons given the evolving Corona virus disease-19 (COVID-19) variant landscape. Hence, no participants were enrolled in Part B and Part C (Cohort-2) of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Part C: Cohort 1-Sotrovimab Participants received a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1. | 98 |
| Part C: Cohort 2-Sotrovimab Participants were planned to receive up to 3000 mg of sotrovimab intravenously on Day 1. | 0 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Part A (Up to Week 35) | Participant was randomized for treatment arm 2 but dosed in treatment arm 4 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A (Up to Week 35) | Participant was randomized for treatment arm 3 but dosed in treatment arm 4 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part A (Up to Week 35) | Randomized but not received treatment | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A (Up to Week 35) | Withdrawal by Subject | 1 | 3 | 2 | 0 | 0 | 0 | 0 |
| Part C (Up to Week 35) | Enrolled but not received treatment | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Part C (Up to Week 35) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Part A: Treatment Arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A: Treatment Arm 2- Sotrovimab 100 mg/mL (Dorsogluteal) | Part A: Treatment Arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh) | Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part C: Cohort 1-Sotrovimab | Total |
|---|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Customized 19-64 years | 70 Participants | 71 Participants | 35 Participants | 38 Participants | 96 Participants | 310 Participants |
| Age, Customized >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 13 Participants | 14 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 2 Participants | 3 Participants | 4 Participants | 16 Participants | 31 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Mixed Asian Race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed Race | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 60 Participants | 62 Participants | 25 Participants | 30 Participants | 61 Participants | 238 Participants |
| Sex: Female, Male Female | 42 Participants | 39 Participants | 21 Participants | 20 Participants | 47 Participants | 169 Participants |
| Sex: Female, Male Male | 29 Participants | 32 Participants | 14 Participants | 18 Participants | 51 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 71 | 0 / 35 | 0 / 38 | 0 / 0 | 0 / 98 | 0 / 0 |
| other Total, other adverse events | 29 / 71 | 22 / 71 | 13 / 35 | 20 / 38 | 0 / 0 | 9 / 98 | 0 / 0 |
| serious Total, serious adverse events | 1 / 71 | 1 / 71 | 0 / 35 | 0 / 38 | 0 / 0 | 0 / 98 | 0 / 0 |
Outcome results
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.
Time frame: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | 944.94 Day*microgram per milliliter |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | 950.67 Day*microgram per milliliter |
90% CI: [0.8825, 1.093]
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.
Time frame: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1 and 2): Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab | 37.91 Microgram per milliliter |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1 and 2): Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab | 44.10 Microgram per milliliter |
90% CI: [1.0108, 1.2539]
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.
Time frame: Up to Day 29
Population: Safety Population consisted of all randomized participants who were exposed to study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | Non-SAEs | 27 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | SAEs | 0 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | AESIs | 24 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | Non-SAEs | 20 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | SAEs | 0 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | AESIs | 15 Participants |
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.
Time frame: Up to Day 29
Population: Safety Population. Data was not collected as no participants were enrolled in Part C: Cohort 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 | Non-SAEs | 9 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 | SAEs | 0 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 | AESIs | 1 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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | 3979.55 Day*microgram per milliliter | Geometric Coefficient of Variation 39.88 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | 3851.37 Day*microgram per milliliter | Geometric Coefficient of Variation 47.68 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | 6397.59 Day*microgram per milliliter | Geometric Coefficient of Variation 20.17 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | 5511.58 Day*microgram per milliliter | Geometric Coefficient of Variation 26.28 |
90% CI: [0.8578, 1.0469]
90% CI: [1.377, 1.7407]
90% CI: [1.2627, 1.5894]
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.
Time frame: Up to Day 29 and Up to Week 35
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | Up to Week 35: SAEs | 1 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | Up to Day 29: SAEs | 0 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | Up to Day 29: AESIs | 24 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | Up to Week 35: AESIs | 25 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | Up to Week 35: Non-SAEs | 29 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | 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 | Up to Day 29: Non-SAEs | 27 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | Up to Week 35: Non-SAEs | 22 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | Up to Week 35: AESIs | 15 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | Up to Day 29: Non-SAEs | 20 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | Up to Week 35: SAEs | 1 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | Up to Day 29: SAEs | 0 Participants |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | 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 | Up to Day 29: AESIs | 15 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Week 35: Non-SAEs | 13 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Day 29: AESIs | 13 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Week 35: SAEs | 0 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Day 29: Non-SAEs | 13 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Week 35: AESIs | 13 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Day 29: SAEs | 0 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Week 35: Non-SAEs | 20 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Week 35: SAEs | 0 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Day 29: Non-SAEs | 20 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Day 29: SAEs | 0 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Day 29: AESIs | 18 Participants |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | 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 | Up to Week 35: AESIs | 18 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: Pre-dose | 0.0 Microgram per milliliter | — |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 57 | 24.5 Microgram per milliliter | Standard Deviation 8.71 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 8 | 38.2 Microgram per milliliter | Standard Deviation 17.92 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 2 hours | 1.8 Microgram per milliliter | Standard Deviation 3.29 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 15 | 38.4 Microgram per milliliter | Standard Deviation 16.78 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 29 | 34.3 Microgram per milliliter | Standard Deviation 12.48 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 6 hours | 6.7 Microgram per milliliter | Standard Deviation 7.17 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 1 hour | 0.6 Microgram per milliliter | Standard Deviation 0.97 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 140 | 9.7 Microgram per milliliter | Standard Deviation 3.84 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 8 hours | 9.9 Microgram per milliliter | Standard Deviation 10.46 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 2 | 19.9 Microgram per milliliter | Standard Deviation 14.34 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 85 | 17.6 Microgram per milliliter | Standard Deviation 5.74 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 3 | 30.0 Microgram per milliliter | Standard Deviation 18.26 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 168 | 7.6 Microgram per milliliter | Standard Deviation 3.46 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 5 | 36.2 Microgram per milliliter | Standard Deviation 18.95 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 5 | 41.8 Microgram per milliliter | Standard Deviation 22.03 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 57 | 24.9 Microgram per milliliter | Standard Deviation 10.91 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 8 hours | 11.1 Microgram per milliliter | Standard Deviation 10.93 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 8 | 42.5 Microgram per milliliter | Standard Deviation 20.95 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 1 hour | 1.6 Microgram per milliliter | Standard Deviation 8.03 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 29 | 35.5 Microgram per milliliter | Standard Deviation 14.13 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 85 | 17.5 Microgram per milliliter | Standard Deviation 7.51 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 15 | 41.6 Microgram per milliliter | Standard Deviation 17.43 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 2 hours | 1.3 Microgram per milliliter | Standard Deviation 1.39 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 3 | 34.4 Microgram per milliliter | Standard Deviation 21.4 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 168 | 6.9 Microgram per milliliter | Standard Deviation 3.09 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 140 | 10.1 Microgram per milliliter | Standard Deviation 8.66 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 2 | 21.7 Microgram per milliliter | Standard Deviation 15.61 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 6 hours | 11.0 Microgram per milliliter | Standard Deviation 15.56 |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: Pre-dose | 0.0 Microgram per milliliter | — |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 5 | 80.3 Microgram per milliliter | Standard Deviation 15.63 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: Pre-dose | 0.0 Microgram per milliliter | — |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 1 hour | 5.0 Microgram per milliliter | Standard Deviation 14.58 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 2 hours | 4.8 Microgram per milliliter | Standard Deviation 13.05 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 6 hours | 14.1 Microgram per milliliter | Standard Deviation 15.1 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 8 hours | 21.2 Microgram per milliliter | Standard Deviation 17.85 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 2 | 45.1 Microgram per milliliter | Standard Deviation 24.51 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 3 | 68.8 Microgram per milliliter | Standard Deviation 22.74 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 8 | 78.9 Microgram per milliliter | Standard Deviation 14.65 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 15 | 67.8 Microgram per milliliter | Standard Deviation 17.61 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 29 | 59.5 Microgram per milliliter | Standard Deviation 12.24 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 57 | 39.3 Microgram per milliliter | Standard Deviation 11.65 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 85 | 27.3 Microgram per milliliter | Standard Deviation 7.73 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 140 | 14.6 Microgram per milliliter | Standard Deviation 4.53 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 168 | 10.1 Microgram per milliliter | Standard Deviation 2.73 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 3 | 53.5 Microgram per milliliter | Standard Deviation 17.6 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 1 hour | 1.4 Microgram per milliliter | Standard Deviation 1.53 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 57 | 33.2 Microgram per milliliter | Standard Deviation 8.36 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 2 | 38.9 Microgram per milliliter | Standard Deviation 16.96 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 8 hours | 18.2 Microgram per milliliter | Standard Deviation 12.51 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: Pre-dose | 0.0 Microgram per milliliter | — |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 85 | 25.8 Microgram per milliliter | Standard Deviation 10.53 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 6 hours | 12.7 Microgram per milliliter | Standard Deviation 7 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 1: 2 hours | 3.1 Microgram per milliliter | Standard Deviation 2.1 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 168 | 10.3 Microgram per milliliter | Standard Deviation 4.01 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 15 | 57.7 Microgram per milliliter | Standard Deviation 11.6 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 8 | 62.6 Microgram per milliliter | Standard Deviation 13.77 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 140 | 13.0 Microgram per milliliter | Standard Deviation 3.83 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 29 | 49.9 Microgram per milliliter | Standard Deviation 13.02 |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab | Day 5 | 63.3 Microgram per milliliter | Standard Deviation 14.41 |
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.
Time frame: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab | 944.94 Day*microgram per milliliter |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab | 1849.83 Day*microgram per milliliter |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab | 1525.17 Day*microgram per milliliter |
90% CI: [1.6391, 2.1472]
90% CI: [1.4086, 1.8153]
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.
Time frame: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 3 and 4): Cmax Following Administration of Sotrovimab | 37.91 Microgram per milliliter |
| Part A: Treatment Arm 2-Sotrovimab 100 mg/mL (Dorsogluteal) | Part A (Treatment Arms 1, 3 and 4): Cmax Following Administration of Sotrovimab | 82.08 Microgram per milliliter |
| Part A: Treatment Arm 4- Sotrovimab 100 mg/mL (Deltoid) | Part A (Treatment Arms 1, 3 and 4): Cmax Following Administration of Sotrovimab | 64.99 Microgram per milliliter |
90% CI: [1.8223, 2.3737]
90% CI: [1.4913, 1.9276]
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.
Time frame: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
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.
Time frame: 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
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Cmax Following Administration of Sotrovimab
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.
Time frame: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
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.
Time frame: Up to Day 29 and Up to Week 35
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
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.
Time frame: 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
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C (Cohorts 1 and 2): AUC(D1-29) Following Administration of Sotrovimab | 12064.44 Day*microgram per milliliter | Geometric Coefficient of Variation 21.5 |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C (Cohorts 1 and 2): Cmax Following Administration of Sotrovimab | 1124.32 Microgram per milliliter | Geometric Coefficient of Variation 21.69 |
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.
Time frame: Up to Week 35
Population: Safety Population. Data was not collected as no participants were enrolled in Part C: Cohort 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35 | SAEs | 0 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35 | Non-SAEs | 9 Participants |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35 | AESIs | 2 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 1: Pre-dose | 0.0 Microgram per milliliter | — |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 1: End of infusion | 1069.2 Microgram per milliliter | Standard Deviation 261.39 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 1: 1 hour | 976.3 Microgram per milliliter | Standard Deviation 265.4 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 1: 2 hours | 993.3 Microgram per milliliter | Standard Deviation 241.85 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 1: 6 hours | 921.5 Microgram per milliliter | Standard Deviation 235.27 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 1: 8 hours | 934.3 Microgram per milliliter | Standard Deviation 224.54 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 2 | 802.9 Microgram per milliliter | Standard Deviation 193.8 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 3 | 685.1 Microgram per milliliter | Standard Deviation 168.11 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 5 | 584.8 Microgram per milliliter | Standard Deviation 149.55 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 8 | 470.9 Microgram per milliliter | Standard Deviation 110.32 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 15 | 407.4 Microgram per milliliter | Standard Deviation 104.25 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 29 | 320.2 Microgram per milliliter | Standard Deviation 74.93 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 57 | 223.9 Microgram per milliliter | Standard Deviation 71.55 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 85 | 159.1 Microgram per milliliter | Standard Deviation 56.97 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 140 | 85.9 Microgram per milliliter | Standard Deviation 32.6 |
| Part A: Treatment Arm 1-Sotrovimab 62.5 mg/mL (Dorsogluteal) | Part C: Serum Concentration Following Administration of Sotrovimab | Day 168 | 61.0 Microgram per milliliter | Standard Deviation 30.72 |