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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

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Trial Profile

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: Discontinued
Phase of Trial: Phase I

Latest Information Update: 28 Sep 2024

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At a glance

  • Drugs Sotrovimab (Primary) ; Sotrovimab (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms COSMIC
  • Sponsors Vir Biotechnology

Most Recent Events

  • 06 Sep 2024 Status changed from recruiting to discontinued. Part C cohort 1 was discontinued early because of evolving variants with changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
  • 24 Mar 2023 Results presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
  • 02 Nov 2022 Treatment arms increase from 6 to 8. Part C Cohort 7 and cohort 8 of concentration 2 of sotrovimab added newly. Primary safety endpoint for part C added newly.

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