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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 is a Phase 1 study that was terminated before completion, run by Vir Biotechnology. The registered enrollment target is 316 participants.
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.
Interventions
- BIOLOGICAL sotrovimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2023-11-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05280717
The ClinicalTrials.gov registry entry for NCT05280717 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vir Biotechnology, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sotrovimab is the first listed.
NCT05280717 reports 0 study locations.
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.
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