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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05844735
The ClinicalTrials.gov registry entry for NCT05844735 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05844735 reports 0 study locations.
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.
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