A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants

Summary

This is a Phase I single-dose study to investigate the pharmacokinetics, safety, and tolerability of sotrovimab vs placebo by intravenous or intramuscular administration in healthy Japanese and Caucasian participants.

Timeline

Start

2021-07-06

Primary completion

2021-09-02

Completion

2021-12-07

Publications

• Nader A, Alexander E, Brintziki D, Haggag AZ, Harrison SA, Hawes IA, Hezareh M, Lippa AM, Okamasa A, Okour M, Okuda N, Sager JE, Segal S, Shida Y, Skingsley A, Williams R, Yoon EY, Austin D. Pharmacokinetics, Safety, and Tolerability of Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers. Clin Pharmacokinet. 2024 Jan;63(1):57-68. doi: 10.1007/s40262-023-01319-2. Epub 2023 Nov 13.

Drugs

Indications