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NCT05844735 · ClinicalTrials.gov registry record · Phase 1
A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05844735: Completed Phase 1 study, sponsored by Sanofi.
NCT05844735 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05844735, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a single center randomized parallel-group partially-blinded, 4-arm Phase 1 study to evaluate the phototoxic potential of two dose levels of SAR441566 treatment compared to placebo and the active comparator, ciprofloxacin, in healthy adults, 18 to 55 years of age. There will be two parts: * Part I is a randomized placebo-controlled trial comparing sensitivity to ultraviolet (UV) light in participants treated with SAR441566 to those treated with placebo. * Part II is an open label arm consisting of participants treated with ciprofloxacin which induces mild phototoxicity and serves as a positive control.
Primary Outcome
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) \[290 to 400 nm\] exposure.
Interventions
- DRUG Placebo
- DRUG Ciprofloxacin
- DRUG SAR441566
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2023-10-23 |
| Phase | Phase 1 |
What the finished NCT05844735 record still lists
NCT05844735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05844735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05844735 about?
NCT05844735 is a clinical study titled "A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566". This is a single center randomized parallel-group partially-blinded, 4-arm Phase 1 study to evaluate the phototoxic potential of two dose levels of SAR441566 treatment compared to placebo and the active comparator, ciprofloxacin, in healthy adults, 18 to 55 years of age. There will be two parts: *...
What is the current status of trial NCT05844735?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-05-22. Estimated completion is 2023-10-23.
What interventions are being tested in trial NCT05844735?
The interventions under investigation include: Placebo (DRUG), Ciprofloxacin (DRUG), SAR441566 (DRUG).
Who is sponsoring clinical trial NCT05844735?
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 NCT05844735's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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