Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)

NCT ID: NCT05280717

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-11-06

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Treatment arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)

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.

Group Type: EXPERIMENTAL

sotrovimab

Intervention Type: BIOLOGICAL

via IM injection

Part A: Treatment arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)

Participants will receive a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.

Group Type: EXPERIMENTAL

sotrovimab

Intervention Type: BIOLOGICAL

via IM injection

Part A: Treatment arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)

Participants will receive a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.

Group Type: EXPERIMENTAL

sotrovimab

Intervention Type: BIOLOGICAL

via IM injection

Part A: Treatment arm 4- Sotrovimab 100 mg/mL (Deltoid)

Participants will receive a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.

Group Type: EXPERIMENTAL

sotrovimab

Intervention Type: BIOLOGICAL

via IM injection

Part B: Sotrovimab

Participants will receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.

Group Type: EXPERIMENTAL

sotrovimab

Intervention Type: BIOLOGICAL

via IM injection

Part C: Cohort 1-Sotrovimab

Participants will receive a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.

Group Type: EXPERIMENTAL

sotrovimab

Intervention Type: BIOLOGICAL

via IV injection

Part C: Cohort 2-Sotrovimab

Participants are planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.

Group Type: EXPERIMENTAL

sotrovimab

Intervention Type: BIOLOGICAL

via IV infusion

Interventions

sotrovimab

via IM injection

Intervention Type: BIOLOGICAL

sotrovimab

via IM injection

Intervention Type: BIOLOGICAL

sotrovimab

via IM injection

Intervention Type: BIOLOGICAL

sotrovimab

via IM injection

Intervention Type: BIOLOGICAL

sotrovimab

via IM injection

Intervention Type: BIOLOGICAL

sotrovimab

via IV injection

Intervention Type: BIOLOGICAL

sotrovimab

via IV infusion

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigative Site

Riverside, California, United States

Investigative Site

Atlantis, Florida, United States

Investigative Site

Edgewater, Florida, United States

Investigative Site

St Louis, Missouri, United States

Investigative Site

Binghamton, New York, United States

Investigative Site

Yukon, Oklahoma, United States

Investigative Site

Medford, Oregon, United States

Investigative Site

Austin, Texas, United States

Investigative Site

Houston, Texas, United States

Investigative Site

West Jordan, Utah, United States

Countries

United States

References

Moore J, Aylott A, Chen WH, Daniluk J, Hawes IA, Parra S, Sarkar P, Sanchez-Pearson Y, Turner M, Peppercorn A, Skingsley A. Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study. MAbs. 2025 Dec;17(1):2456467. doi: 10.1080/19420862.2025.2456467. Epub 2025 Jan 29.

Reference Type: DERIVED

PMID: 39881564 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GSK Study 218128

Identifier Type: OTHER

Identifier Source: secondary_id

VIR-7831-5012

Identifier Type: -

Identifier Source: org_study_id