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

NCT05844735 | Completed Phase 1 FDA Drug

• 2 other identifiers: PDY16917U1111-1255-5054
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

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

  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.

  On-drug Day 8

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

  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.

  On-drug Day 8

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

  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.

  On-drug Day 9

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

  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.

  On-drug Day 8

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

  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.

  On-drug Day 8

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

  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.

  On-drug Day 9

Secondary Outcomes (12)

• 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

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

• 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

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

• Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Cmax

  Day 8 to Day 11

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

  Day 8 to Day 11

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

  Day 8 to Day 9

Study Arms (4)

Part I SAR441566 Dose A

EXPERIMENTAL

Participants will receive repeated low dose of SAR441566 for 7.5 days

Drug: SAR441566

Part I SAR441566 Dose B

EXPERIMENTAL

Participants will receive repeated high dose of SAR441566 for 7.5 days

Drug: SAR441566

Part I Placebo

PLACEBO COMPARATOR

Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days

Drug: Placebo

Part II Ciprofloxacin

ACTIVE COMPARATOR

Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days

Drug: Ciprofloxacin

Interventions

SAR441566 DRUG

Tablet

Part I SAR441566 Dose A; Part I SAR441566 Dose B

Placebo DRUG

Tablet

Part I Placebo

Ciprofloxacin DRUG

Tablet

Part II Ciprofloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

TKL Research, Inc. Site Number : 8400001

Fair Lawn, New Jersey, 07410, United States

Location

Related Links

• PDY16917 Plain Language Results Summary

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Applicable for Part I
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: May 22, 2023
• Primary Completion: October 15, 2023
• Study Completion: October 23, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)