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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05844735
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis
Additional Details

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

Arms & Interventions

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

Interventions

Drug: - SAR441566

Tablet

Drug: - Placebo

Tablet

Drug: - Ciprofloxacin

Tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

TKL Research, Inc.-Site Number:8400001, Fair Lawn, New Jersey

Status

Recruiting

Address

TKL Research, Inc.-Site Number:8400001

Fair Lawn, New Jersey, 07410

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