Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT05007756
Eligibility Criteria:
Inclusion Criteria:
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-HCG\]) at screening and a negative urine pregnancy test prior to study intervention administration on Day -4
* Must have Fitzpatrick skin type II or III (10 participants) or type IV or higher (2 participants)
* Otherwise healthy on the basis of physical examination, medical history, and vital signs, and, if required by the applicable Intervention Specific Appendix (ISA), a 12-lead Electrocardiography (ECG) performed at screening. Any abnormalities must be considered not clinically significant or consistent with the underlying illness in the study population and this determination must be recorded
* Otherwise healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example, nicotine patch) for 3 months prior to screening
Exclusion Criteria:
* Has a history of dysplastic melanocytic nevi or skin cancer
* Known hypersensitivity, intolerance to UV/sunlight exposure, or any condition associated with photosensitivity
* Has Fitzpatrick skin type I, as determined by the investigator. A person with Fitzpatrick skin type I typically has unexposed skin that is bright white with frequent freckling, has blue/green eyes, and is of Northern European/British descent. They typically burn, peel, and don't tan in response to ultraviolet B (UVB)
* Has a history of chronic skin conditions, such as vitiligo, psoriasis, rosacea, severe eczema, or atopic dermatitis, and/or severe acne that would complicate or preclude evaluation of the minimal erythema dose (MED) testing and UVB challenge sites
* Has used topical antibiotics or topical corticosteroids within 1 month prior to study intervention administration and/or has a history of extensive and prolonged use (greater than \[\>\] 3 months) of topical antibiotics or topical corticosteroids
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05007756
Study Brief:
Protocol Section:
NCT05007756