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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODPCNAP0002 | Other Identifier | Janssen Research & Development, LLC | |
| PLATFORMPCNAP0001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultraviolet B (UVB) Challenge | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UVB Challenge | Radiation | UVB challenge will be administered dermally through Lumera Phototherapy System. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Gene Expression as Measured by Counts of Transcript per Million Reads | Changes in gene expression as measured by counts of transcript per million reads in control versus challenged tissue will be reported. | Up to Week 6 |
| Changes in Gene Set Variation Analysis Enrichment Score | Changes in gene set variation analysis (GSVA) enrichment score control versus challenged tissue will be reported. The GSVA score is a measurement of changes in a set of genes between 2 sample sets (example, control versus test). | Up to Week 6 |
| Changes in Cell Count as Measured by Fluorescence Intensity | Changes in cell count as measured by fluorescence intensity via immunohistochemistry (IHC) in control versus challenged tissue will be reported. | Up to Week 6 |
| Changes in Protein Expression as Measured by Fluorescence Intensity | Changes in protein expression as measured by fluorescence intensity via IHC in control versus challenged tissue will be reported. | Up to Week 6 |
| Changes in Gene Expression as Measured by Fluorescence Intensity | Changes in gene expression as measured by fluorescence intensity via IHC in control versus challenged tissue will be reported. | Up to Week 6 |
| Changes in the Levels of Proteins and Phosphoproteins | Changes in the levels of proteins and phosphoproteins which are relevant to inflammatory pathways thought to be activated by ultraviolet B (UVB) exposure (example, Type 1 interferons pathways) measured by enzyme-linked immunoassay (ELISA) in control versus challenged tissue lysates, will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Changes in Gene Expression as Measured by Counts of Transcript per Million Reads | Standard deviation of changes in gene expression as measured by counts of transcript per million reads in control versus challenged tissue will be reported. | Up to Week 6 |
| Standard Deviation of Changes in GSVA Enrichment Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Up to Week 6 |
| Fold Changes in the Mean Differences of the Levels of Proteins and Phosphoproteins | Fold changes in the mean differences of the levels of the proteins and phosphoproteins which are relevant to inflammatory pathways thought to be activated by UVB exposure (example, type 1 interferons pathways) measured by ELISA in control versus challenged tissue lysates, will be reported. | Up to Week 6 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Week 6 |
| Number of Participants with Treatment-emergent Serious Adverse Events (SAEs). | A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state. | Up to Week 6 |
| 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 | Number of participants with TEAEs by MedDRA SOC with a frequency threshold of at least 2 participants per intervention cohort will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Week 6 |
Standard deviation of changes in GSVA enrichment score will be reported. The GSVA score is a measurement of changes in a set of genes between 2 sample sets (example, control versus test). |
| Up to Week 6 |
| Standard Deviation of Changes in Cell Count as Measured by Fluorescence Intensity | Standard deviation of changes in cell count as measured by fluorescence intensity via IHC in control versus challenged tissue will be reported. | Up to Week 6 |
| Standard Deviation of Changes in Protein Expression as Measured by Fluorescence Intensity | Standard deviation of changes in protein expression as measured by fluorescence intensity via immunohistochemistry (IHC) in control versus challenged tissue will be reported. | Up to Week 6 |
| Standard Deviation of Changes in Gene Expression as Measured by Fluorescence Intensity | Standard deviation of changes in gene expression as measured by fluorescence intensity via IHC in control versus challenged tissue will be reported. | Up to Week 6 |
| Standard Deviation of Changes in Phosphoproteins and Other Proteins | Standard deviation of changes in phosphoproteins and other proteins in tissue lysate in control versus challenged tissue will be reported. | Up to Week 6 |
| Standard Deviation of Fold Changes of Means of Phosphoproteins and Other Proteins | Standard deviation of fold changes of means of phosphoproteins and other proteins in control versus challenged tissue will be reported. | Up to Week 6 |