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

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.

Timeline

Start

2022-03-28

Primary completion

2023-04-05

Completion

2023-11-06

Publications

• 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.
• 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.

Drugs

Indications