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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants (biological replicates) that were successfully sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of \< 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types.
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 |
What the finished NCT02798523 record still lists
NCT02798523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone sodium succinate(Solu-Medrol) is the first listed.
NCT02798523 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02798523's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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