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

Part of paid clinical trials in Fair Lawn, New Jersey.

Sponsor
Sanofi
Study ID
NCT05844735
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • SAR441566 — DRUG
    Tablet
  • Placebo — DRUG
    Tablet
  • Ciprofloxacin — DRUG
    Tablet

Study Details

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.

Key Dates

First listed
May 6, 2023
Start date
May 22, 2023
Status verified
Sep 2025
Primary completion
Oct 15, 2023
Completion
Oct 23, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I SAR441566 Dose A
    Participants will receive repeated low dose of SAR441566 for 7.5 days
  • Experimental: Part I SAR441566 Dose B
    Participants will receive repeated high dose of SAR441566 for 7.5 days
  • Placebo Comparator: Part I Placebo
    Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days
  • Active Comparator: Part II Ciprofloxacin
    Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days

Primary Outcome Measure

Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1 [ Time Frame: On-drug Day 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
TKL Research, Inc. Site Number : 8400001Fair LawnNew Jersey07410-

Find similar trials in Fair Lawn, NJ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
TKL Research, Inc.· Fair Lawn, NJ

Related Studies