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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
UVB challenge will be administered dermally through Lumera Phototherapy System.
Clinical Pharmacology Unit
Merksem, Belgium
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 6
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.
Time frame: Up to Week 6
Standard Deviation of Changes in GSVA Enrichment Score
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 6