Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) - Trial NCT05280717
Access comprehensive clinical trial information for NCT05280717 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vir Biotechnology, Inc. and is currently Recruiting. The study focuses on Covid19. Target enrollment is 504 participants.
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Study Focus
Sponsor & Location
Vir Biotechnology, Inc.
Timeline & Enrollment
Phase 1
Mar 28, 2022
May 30, 2024
Primary Outcome
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,Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through 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,Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05280717
Non-Device Trial