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Corticosteroid
Methylprednisolone sodium succinate(Solu-Medrol) for Normal Physiology
Phase 1
Waitlist Available
Led By Luis M Franco, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 to 64 years
Willingness to have samples stored for future research
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is studying how human genes respond to the drug glucocorticoid (GC). Researchers want to learn how to develop better drugs that have the benefits of GCs without the side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
Secondary outcome measures
To identify potential targets for small-molecule or nanoparticle- facilitated RNA interference interventions that reproduce the therapeutic action of glucocorticoids while avoiding harmful effects
Trial Design
2Treatment groups
Experimental Treatment
Group I: Up to 4 hours post infusionExperimental Treatment2 Interventions
Healthy volunteers received a single intravenous dose of 250 mg of methylprednisolone and blood was collected between two hours to four hours after the start of the infusion.
Group II: Up to 2 hours post infusionExperimental Treatment1 Intervention
Healthy volunteers received a single intravenous dose of 250 mg of methylprednisolone and blood was collected between one to two hours after the start of the infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone sodium succinate(Solu-Medrol)
2017
Completed Phase 1
~40
Topical methylprednisolone (Advantan emulsion 0 /1%)
2017
Completed Phase 1
~40
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,973 Total Patients Enrolled
4 Trials studying Normal Physiology
584 Patients Enrolled for Normal Physiology
Luis M Franco, M.D.Principal InvestigatorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 Previous Clinical Trials
47 Total Patients Enrolled
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