A Study Exploring the Use of Challenge Agents in Healthy Volunteers or Participants With a Disease of Interest

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Radiation: UVB Challenge

Study type: Interventional

Funder types: Industry

Identifiers

NCT05007756

NOPRODPCNAP0002 (Other Identifier)

PLATFORMPCNAP0001 (Other Identifier)

CR109034

Details and patient eligibility

About

The purpose of this study is to characterize the biological response in vivo to challenge agents (vaccines, antigen, drug, or mechanical challenges); to assess the safety and tolerability of the challenge agent and to characterize the immune response in skin elicited in vivo in healthy volunteers using an ultraviolet B (UVB) challenge.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Ultraviolet B (UVB) Challenge

Experimental group

Description:

Participants will receive UVB (various doses) for minimal erythema dose (MED) assessment at baseline following which there will be washout period. Participants will then receive a single dose of UVB challenge dermally through Lumera Phototherapy System on Day 1, twice (2\*) the MED at the challenge site with no UVB exposure at the contralateral control site.

Treatment:

Radiation: UVB Challenge