NCT05844735

A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566

A Two-part, Randomized Partially-blinded, Parallelgroup, Placebo- and Active Comparatorcontrolled Phase 1 Study to Evaluate the Photosafety of Repeated Oral Dose of SAR441566 in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The overall duration of the study for each participant will be up to approximately 48 days

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SAR441566	Tablet
DRUG	Placebo	Tablet
DRUG	Ciprofloxacin	Tablet

Timeline

• Start date: 2023-05-22
• Primary completion: 2023-10-15
• Completion: 2023-10-23
• First posted: 2023-05-06
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study