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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
Vir Biotechnology, Inc.·Phase 1·ClinicalTrials.gov·biologicalRecruiting
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Study focus
Disease/Condition
Covid19
Drug/Device/Intervention
sotrovimab
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Vir Biotechnology, Inc.
Location
Riverside,Atlantis,Edgewater,Saint Louis,Binghamton,Yukon,Medford,Austin,Houston,West Jordan, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 28, 2022
End date
May 30, 2024
Enrollment
504 participants
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
COVID-19, virus identifiedCOVID-19, virus not identifiedCoronavirus infection, unspecified siteRift Valley feverPlague
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05280717
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.