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

Studying the Light-Sensitivity Effects of SAR441566 in Healthy Adults

Not Recruiting
18 years - 55 years
All
Phase 1
60 participants needed

Study Overview

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.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rheumatoid Arthritis
  • Age: 18 years - 55 years
  • Gender: All

Inclusion Criteria:

  • Male or female participants who are between 18 and 55 years of age, (inclusive), at the time of signing the informed consent
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
  • Participants with Fitzpatrick skin type classification of I, II, or III (I always burns easily, never tans, II always burns easily, tans minimally, III Burns moderately, tans gradually)
  • Body weight within 50.0 and 100.0 kg (inclusive), and body mass index (BMI) within the range 18.0 and 32.0 kg/m2 (inclusive)

Exclusion Criteria:

  • A positive hepatitis B (HBsAg, anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection
  • A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT)
  • History of invasive opportunistic infections
  • Participants with a history of Clostridium difficile-associated diarrhea
  • Participants with a history of malignancy occurring within 5 years before inclusion (except adequately treated carcinoma in situ of the cervix, or adequately treated non-metastatic squamous cell or basal cell carcinoma of the skin)
  • Active skin disorders or alterations such as tattoos on the back where photosensitivity testing will be performed or unprotected ultraviolet exposure of the test areas within 4 weeks prior to baseline photo testing that the Investigator considers will interfere with study assessments
  • Abnormal skin response during preliminary or baseline phototoxicity evaluations
  • Any medication within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication (whichever is longer); any acetaminophen intake within 2 days prior the inclusion and any biologics (antibody or its derivatives) given within 4 months before screening
  • Any participant enrolled or having participated, in this or any other clinical study involving an IMP or in any other type of medical research within the past 14 days (last day of IMP dosing in the previous clinical trial) or 5 half-lives whichever is longer, before screening
  • Clinical signs and symptoms consistent with COVID-19 or laboratory-confirmed SARS-CoV-2 infection; SARS-CoV-2 infection within 4 weeks prior to screening; and/or history of severe course of COVID-19
  • If female, pregnancy (defined as positive beta-HCG blood test and/or positive urine pregnancy test), breast-feeding
        The above information is not intended to contain all considerations relevant to a potential
        participation in a clinical trial.

Updated on 18 Jan 2024. Study ID: NCT05844735

This study investigates the phototoxic potential, which means the likelihood of a substance to cause skin reactions when exposed to light, of an investigational medication called SAR441566. The study involves healthy adults aged 18 to 55 years. Participants will be divided into four study arms: two different doses of SAR441566, a placebo arm, and an active comparator arm using ciprofloxacin, which is known to cause mild phototoxicity and serves as a positive control.

Participants in the study will undergo procedures to test their skin's sensitivity to ultraviolet (UV) light. In Part I, participants will be randomly assigned to receive either SAR441566 or a placebo, and their skin's reaction to UV light will be compared. In Part II, participants will receive ciprofloxacin to observe its phototoxic effects. Phototoxicity testing involves exposing small areas of skin to UV light to see if any reactions occur.

  • Who can participate: Healthy adults aged 18 to 55 years with Fitzpatrick skin types I, II, or III can participate. Participants must have a body weight between 50 and 100 kg and a BMI between 18.0 and 32.0 kg/m². Exclusion criteria include a history of certain infections, recent medication use, and active skin disorders.
  • Study details: Participants will be assigned to different study arms to test the phototoxic potential of SAR441566. Some will receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. Others will receive ciprofloxacin as a positive control. The study involves testing skin reactions to UV light exposure.
  • Study Timelines: The study will last approximately 48 days.