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NCT04988152 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants
A Phase 1 study, sponsored by Vir Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT04988152: Completed Phase 1 study, sponsored by Vir Biotechnology.
NCT04988152 is a Phase 1 study that has completed, run by Vir Biotechnology. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04988152, a Phase 1 study, has completed, sponsored by Vir Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a Phase I single-dose study to investigate the pharmacokinetics, safety, and tolerability of sotrovimab vs placebo by intravenous or intramuscular administration in healthy Japanese and Caucasian participants.
Primary Outcome
The Cmax was summarized using standard non-compartmental pharmacokinetic analysis methods. The geometric means and geometric coefficient of variation are presented. An ethnicity comparison (Japanese versus Caucasian) was also conducted using analysis of covariance (ANCOVA) adjusting for body weight. The geometric Least Square (LS) means ratio (Japanese versus Caucasian) for Cmax and 90 percent (%) confidence interval (CI) are presented.
Interventions
- BIOLOGICAL sotrovimab
- OTHER Placebo to Biologic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-07-06 |
| Est. Completion | 2021-12-07 |
| Phase | Phase 1 |
What the finished NCT04988152 record still lists
NCT04988152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which sotrovimab is the first listed.
NCT04988152 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04988152 about?
NCT04988152 is a clinical study titled "A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants". This is a Phase I single-dose study to investigate the pharmacokinetics, safety, and tolerability of sotrovimab vs placebo by intravenous or intramuscular administration in healthy Japanese and Caucasian participants.
What is the current status of trial NCT04988152?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2021-07-06. Estimated completion is 2021-12-07.
What interventions are being tested in trial NCT04988152?
The interventions under investigation include: sotrovimab (BIOLOGICAL), Placebo to Biologic (OTHER).
Who is sponsoring clinical trial NCT04988152?
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 NCT04988152's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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