drugset / Trial / NCT05844735

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

NCT05844735

Phase 1 Completed 60 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-05-22
Primary completion
2023-10-15
Completion
2023-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Balinatunfib Small molecule Oral
Comparator Ciprofloxacin Small molecule 500 mg

Indications