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NCT05858788 · ClinicalTrials.gov registry record · Phase 1
A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05858788: Completed Phase 1 study, sponsored by Sanofi.
NCT05858788 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05858788, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.
Primary Outcome
Maximum plasma concentration observed
Interventions
- DRUG SAR441566
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2023-07-17 |
| Phase | Phase 1 |
What the finished NCT05858788 record still lists
NCT05858788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which SAR441566 is the first listed.
NCT05858788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05858788 about?
NCT05858788 is a clinical study titled "A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.". This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.
What is the current status of trial NCT05858788?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-05-15. Estimated completion is 2023-07-17.
What interventions are being tested in trial NCT05858788?
The interventions under investigation include: SAR441566 (DRUG).
Who is sponsoring clinical trial NCT05858788?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05858788's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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