A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
Status:
Not yet recruiting
Trial end date:
2023-09-27
Target enrollment:
Participant gender:
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.