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.
The overall duration of the study for each participant will be up to approximately 48 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Tablet
Tablet
Tablet
TKL Research, Inc. Site Number : 8400001
Fair Lawn, New Jersey, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On-drug Day 9
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
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.
Time frame: 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
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.
Time frame: 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
Maximum plasma concentration observed
Time frame: Day 8 to Day 11
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Tmax,
Time to reach Cmax
Time frame: Day 8 to Day 11
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: AUC0-tau
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (0 to 24 hours)
Time frame: Day 8 to Day 9
Treatment part I: Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including serious adverse event (SAE) and adverse event of special interests (AESI)
Time frame: Up to Day 20
Treatment part II: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Condition 1 is full range solar UVB/UVA \[290 to 400 nm\] exposure.
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1
Condition 1 is full range solar UVB/UVA \[290 to 400 nm\] exposure.
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1
Condition 1 is full range solar UVB/UVA \[290 to 400 nm\] exposure.
Time frame: On-drug Day 9
Treatment part II: Photosensitivity Index (PI) at 10 minutes Condition 2
Condition 2 is a UVA only \[320 to 400 nm\] exposure.
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2
Condition 2 is a UVA only \[320 to 400 nm\] exposure.
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2
Condition 2 is a UVA only \[320 to 400 nm\] exposure.
Time frame: On-drug Day 9