Clinical trial NCT05007756: A Study Exploring the Use of Challenge Agents in Healthy Volunteers or Participants With a Disease of Interest
Official title: A Phase 0 Platform Study Exploring the Use of Challenge Agents in Healthy Volunteers or Participants With a Disease of Interest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: Changes in Gene Expression as Measured by Counts of Transcript per Million Reads
timeFrame: Up to Week 6
measure: Changes in Gene Set Variation Analysis Enrichment Score
timeFrame: Up to Week 6
measure: Changes in Cell Count as Measured by Fluorescence Intensity
timeFrame: Up to Week 6
measure: Changes in Protein Expression as Measured by Fluorescence Intensity
timeFrame: Up to Week 6
measure: Changes in Gene Expression as Measured by Fluorescence Intensity
timeFrame: Up to Week 6
measure: Changes in the Levels of Proteins and Phosphoproteins
timeFrame: Up to Week 6
measure: Fold Changes in the Mean Differences of the Levels of Proteins and Phosphoproteins
timeFrame: Up to Week 6
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 6
measure: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs).
timeFrame: Up to Week 6
measure: Number of Participants with TEAEs by Medical Dictionary for Regulatory Activities (MedDRA) System-organ Class (SOC) with a Frequency Threshold of at Least 2 Participants per Intervention Cohort
timeFrame: Up to Week 6
Secondary outcomes:
measure: Standard Deviation of Changes in Gene Expression as Measured by Counts of Transcript per Million Reads
timeFrame: Up to Week 6
measure: Standard Deviation of Changes in GSVA Enrichment Score
timeFrame: Up to Week 6
measure: Standard Deviation of Changes in Cell Count as Measured by Fluorescence Intensity
timeFrame: Up to Week 6
measure: Standard Deviation of Changes in Protein Expression as Measured by Fluorescence Intensity
timeFrame: Up to Week 6
measure: Standard Deviation of Changes in Gene Expression as Measured by Fluorescence Intensity
timeFrame: Up to Week 6
measure: Standard Deviation of Changes in Phosphoproteins and Other Proteins
timeFrame: Up to Week 6
measure: Standard Deviation of Fold Changes of Means of Phosphoproteins and Other Proteins
timeFrame: Up to Week 6
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: