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NCT02798523 · ClinicalTrials.gov registry record · Phase 1
Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT02798523 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 33 participants.
The verdict
NCT02798523, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study 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.
Interventions
- DRUG Methylprednisolone sodium succinate(Solu-Medrol)
- DRUG Topical methylprednisolone (Advantan emulsion 0 /1%)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-01-24 |
| Est. Completion | 2022-11-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02798523
The ClinicalTrials.gov registry entry for NCT02798523 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone sodium succinate(Solu-Medrol) is the first listed.
NCT02798523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02798523 about?
NCT02798523 is a clinical study titled "Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids". 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...
What is the current status of trial NCT02798523?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2017-01-24. Estimated completion is 2022-11-14.
What interventions are being tested in trial NCT02798523?
The interventions under investigation include: Methylprednisolone sodium succinate(Solu-Medrol) (DRUG), Topical methylprednisolone (Advantan emulsion 0 /1%) (DRUG).
Who is sponsoring clinical trial NCT02798523?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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