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NCT01847573 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy
A Phase 1 study, sponsored by Processa Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01847573: Clinical Trial Phase 1 study, sponsored by Processa Pharmaceuticals.
NCT01847573 is a Phase 1 study that was terminated before completion, run by Processa Pharmaceuticals. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01847573, a Phase 1 study, was terminated before completion, sponsored by Processa Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The main purpose of this study is to test the safety and tolerability of different, increasing doses of an experimental medication called HT-100 in boys and young men with Duchenne muscular dystrophy (DMD). The study medication, HT-100, is a medicine that may help promote healthy muscle regeneration, diminish inflammation and the resulting damage to muscle, and decrease the scar tissue that forms in the muscles of children with DMD. In this study, pharmacokinetic sampling, or measurements of the amount of HT-100 in the bloodstream will also be taken.
Primary Outcome
Safety profile by review of adverse events (AEs), physical examination findings, clinical laboratory test results, and other diagnostic testing
Interventions
- DRUG HT-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-03-30 |
| Phase | Phase 1 |
Why NCT01847573 stopped before completion
NCT01847573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which HT-100 is the first listed.
NCT01847573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01847573 about?
NCT01847573 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy". The main purpose of this study is to test the safety and tolerability of different, increasing doses of an experimental medication called HT-100 in boys and young men with Duchenne muscular dystrophy (DMD). The study medication, HT-100, is a medicine that may help promote healthy muscle regeneration...
What is the current status of trial NCT01847573?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-05. Estimated completion is 2016-03-30.
What interventions are being tested in trial NCT01847573?
The interventions under investigation include: HT-100 (DRUG).
Who is sponsoring clinical trial NCT01847573?
This trial is sponsored by Processa Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01847573's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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