NCT05280717

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	sotrovimab	via IM injection
BIOLOGICAL	sotrovimab	via IM injection
BIOLOGICAL	sotrovimab	via IM injection
BIOLOGICAL	sotrovimab	via IM injection
BIOLOGICAL	sotrovimab	via IM injection
BIOLOGICAL	sotrovimab	via IV injection
BIOLOGICAL	sotrovimab	via IV infusion

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-04-05
• Completion: 2023-11-06
• First posted: 2022-03-15
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study