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Completed

NCT Number: NCT05844735

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TKL Research, Inc. Site Number : 8400001

Fair Lawn, New Jersey, 07410, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR441566

Drug

Tablet

Placebo

Drug

Tablet

Ciprofloxacin

Drug

Tablet

Primary outcomes

  1. Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1

    Time frame: On-drug Day 8

    The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation.

    Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) [290 to 400 nm] exposure.

  2. Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1

    Time frame: On-drug Day 8

    The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation.

    Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.

  3. Treatment part I: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1

    Time frame: On-drug Day 9

    The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation.

    Condition 1 is a Full range solar UVB/UVA [290 to 400 nm] exposure.

  4. Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 2

    Time frame: On-drug Day 8

    The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation.

    Condition 2 is a UVA only [320 to 400 nm] exposure.

  5. Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2

    Time frame: On-drug Day 8

    The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation.

    Condition 2 is a UVA only [320 to 400 nm] exposure.

  6. Treatment part I: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2

    Time frame: On-drug Day 9

    The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation.

    Condition 2 is a UVA only [320 to 400 nm] exposure.

Secondary outcomes

  1. Treatment part I & part II: Minimum Erythema Dose (MED) percent change from baseline at 10 minutes, 1 hour, and 24 hours postirradiation measured under Condition 1 and Condition 2

    Time frame: Baseline (Day -2 to Day -1) and on-drug (Day 8 to Day 9)

    Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure and condition 2 is a UVA only [320 to 400 nm] exposure.

  2. Treatment part I & part II: Evaluation of local skin reactions following exposure to UV irradiation at 10 minutes, 1 hour, 24 hours, 48 hours, and 72 hours postirradiation under Condition 1, Condition 2, and Condition 3

    Time frame: At Baseline (Day -2 to Day 1 pre-dose) and on-drug (Day 8 to Day 11)

    Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure, condition 2 is a UVA only [320 to 400 nm] exposure and condition 3 is a full solar range UVB/UVA + UVA [16 J/cm2] exposure.

  3. Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Cmax

    Time frame: Day 8 to Day 11

    Maximum plasma concentration observed

  4. Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Tmax,

    Time frame: Day 8 to Day 11

    Time to reach Cmax

  5. Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: AUC0-tau

    Time frame: Day 8 to Day 9

    Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (0 to 24 hours)

  6. Treatment part I: Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)

    Time frame: Up to Day 20

    Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including serious adverse event (SAE) and adverse event of special interests (AESI)

  7. Treatment part II: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1

    Time frame: On-drug Day 8

    Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.

  8. Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1

    Time frame: On-drug Day 8

    Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.

  9. Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1

    Time frame: On-drug Day 9

    Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.

  10. Treatment part II: Photosensitivity Index (PI) at 10 minutes Condition 2

    Time frame: On-drug Day 8

    Condition 2 is a UVA only [320 to 400 nm] exposure.

  11. Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2

    Time frame: On-drug Day 8

    Condition 2 is a UVA only [320 to 400 nm] exposure.

  12. Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2

    Time frame: On-drug Day 9

    Condition 2 is a UVA only [320 to 400 nm] exposure.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Two-part, Randomized Partially-blinded, Parallelgroup, Placebo- and Active Comparatorcontrolled Phase 1 Study to Evaluate the Photosafety of Repeated Oral Dose of SAR441566 in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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