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NCT05280717 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
A Phase 1 study, sponsored by Vir Biotechnology.
- Terminated
- Registry status
- Phase 1
- Development phase
- 316
- Enrollment target
NCT05280717: Clinical Trial Phase 1 study, sponsored by Vir Biotechnology.
NCT05280717 is a Phase 1 study that was terminated before completion, run by Vir Biotechnology. The registered enrollment target is 316 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (427% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05280717, a Phase 1 study, was terminated before completion, sponsored by Vir Biotechnology.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 316 participants
- Enrollment target
Study 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.
Primary Outcome
Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis.
Interventions
- BIOLOGICAL sotrovimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2023-11-06 |
| Phase | Phase 1 |
Why NCT05280717 stopped before completion
NCT05280717 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (427% higher).
The record links to 0 conditions, and to 1 intervention - of which sotrovimab is the first listed.
NCT05280717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05280717 about?
NCT05280717 is a clinical study titled "Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)". 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 pa...
What is the current status of trial NCT05280717?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 316 participants. The study started on 2022-03-28. Estimated completion is 2023-11-06.
What interventions are being tested in trial NCT05280717?
The interventions under investigation include: sotrovimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05280717?
This trial is sponsored by Vir Biotechnology, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05280717's enrollment target sits among peer trials
316 117th of 2000 higher than 1,884 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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