Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Background:
The immune system defends the body against bacteria and other harmful invaders. But it can
overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs)
can calm down an overactive immune system. But they often cause negative side effects.
Researchers want to learn how human genes respond to GCs. Genes live inside each cell of the
body. They tell our cells how to function. Researchers hope the results of this study will
show them how to develop better drugs that will have the benefits of GCs without the side
effects.
Objectives:
To study how human genes respond to glucocorticoid drugs.
Eligibility:
Healthy adult volunteers ages 18 64.
Design:
Participants will be screened with a medical history and physical exam. They will have a
heart test and blood tests.
The study visit will last about 6 hours.
Participants will have medical history, physical exam, and 3 blood draws.
Participants will have a skin biopsy. An injection will numb the skin on one arm. Then a tool
will remove a piece of skin about as big as a pencil eraser.
A GC cream will be applied to the other arm.
Participants will get the GC study drug for 30 minutes. It will be a liquid that will drip
through a needle placed in an arm vein.
Participants will have a skin biopsy of the arm that had the cream applied.
Participants will have follow-up calls 1 and 4 days later. They will be asked about reactions
or other health problems.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)