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

A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years

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).

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: sotrovimab; Biological: sotrovimab

• Study Type: Interventional
• Enrollment (Anticipated): 504
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Inquiry; Phone Number: 4156545281; Email: clinicaltrials@vir.bio

Study Locations

• United States
  • California
    • Riverside, California, United States, 92503
      • Recruiting
      • Investigative Site
  • Florida
    • Atlantis, Florida, United States, 33462
      • Recruiting
      • Investigative Site
    • Edgewater, Florida, United States, 32132
      • Recruiting
      • Investigative Site
      • Contact: Study Inquiry
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Recruiting
      • Investigative Site
  • New York
    • Binghamton, New York, United States, 13901
      • Recruiting
      • Investigative Site
  • Oklahoma
    • Yukon, Oklahoma, United States, 73099
      • Recruiting
      • Investigative Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Recruiting
      • Investigative Site
      • Contact: Study Inquiry
  • Texas
    • Austin, Texas, United States, 78745
      • Recruiting
      • Investigative Site
    • Houston, Texas, United States, 77065
      • Recruiting
      • Investigative Site
  • Utah
    • West Jordan, Utah, United States, 84088
      • Recruiting
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Cohort 1: Concentration 1 of sotrovimab; administered at injection site 1	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion
Experimental: Part A Cohort 2: Concentration 2 of sotrovimab; administered at injection site 1	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion
Experimental: Part A Cohort 3: Concentration 2 of sotrovimab; administered at injection site 2	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion
Experimental: Part A Cohort 4: Concentration 2 of sotrovimab; administered at injection site 3	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion
Experimental: Part B Cohort 5: Concentration 1 of sotrovimab; administered at potential injection site 1,2,3 or other	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion
Experimental: Part B Cohort 6: Concentration 2 of sotrovimab; administered at potential injection site 1,2,3 or other	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion
Experimental: Part C Cohort 7: Concentration 2 of sotrovimab; administered by intravenous (IV) infusion	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion
Experimental: Part C Cohort 8: Concentration 2 of sotrovimab; administered by IV infusion	Biological: sotrovimab; via IM injection; Biological: sotrovimab; via IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A (Cohort 1, 2): Area under the serum concentration-time curve (AUC) from Day 1 to Day 29 (AUC D1-29) following administration of sotrovimab	Up to Day 29
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29	Up to Day 29
Part A (Cohort 1, 2): Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) through Day 29	Up to Day 29
Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI	Up to Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab	Up to Day 29
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29	Up to Day 29
Part A (Cohort 1, 2, 3, 4): Area under the serum concentration-time curve from time zero to infinity (AUCinf) following administration of sotrovimab at injection sites 1, 2 and 3 through Week 24	Up to Week 24
Part A: Serum concentration following administration of sotrovimab through Day 29	Up to Day 29
Part A: Serum concentration following administration of sotrovimab through Week 24	Up to Week 24
Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI	Up to Day 29
Part A and Part B: Number of participants with AEs, SAEs, and AESI	Up to Week 35
Part B: AUC(D1-29) following administration of sotrovimab	Up to Day 29
Part B: Cmax following administration of sotrovimab through Day 29	Up to Day 29
Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24	Up to Week 24
Part B: Serum concentration following administration of sotrovimab through Day 29	Up to Day 29
Part B: Serum concentration following administration of sotrovimab through Week 24	Up to Week 24
Part C: AUC(D1-29) following administration of sotrovimab	Up to Day 29
Part C: Cmax following administration of sotrovimab through Day 29	Up to Day 29
Part C: Serum concentration following administration of sotrovimab through Day 29	Up to Day 29
Part C: Serum concentration following administration of sotrovimab through Week 24	Up to Week 24
Part C: Number of participants with AEs, SAEs, and AESI	Up to Week 35

Collaborators and Investigators

• Sponsor: Vir Biotechnology, Inc.
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Anticipated): March 4, 2024
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; COVID-19; Healthy participants; Relative bioavailability; Sotrovimab
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: VIR-7831-5012; GSK Study 218128 (Other Identifier: GlaxoSmithKline)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No