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NCT04184882 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)
A Phase 1 study, sponsored by Astellas Pharma.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04184882: Clinical Trial Phase 1 study, sponsored by Astellas Pharma.
NCT04184882 is a Phase 1 study that was terminated before completion, run by Astellas Pharma. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04184882, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the safety and tolerability of ASP0367. This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle function of ASP0367.
Primary Outcome
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE observed after starting administration of the investigational product (IP) to 28 days after the last dose of IP for the double blind part or moving to the open-label extension part, whichever comes first. An IP-related TEAE is defined as any TEAE with a causal relationship of "yes" b
Interventions
- DRUG Placebo
- DRUG Bocidelpar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2022-09-04 |
| Phase | Phase 1 |
Why NCT04184882 stopped before completion
NCT04184882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04184882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04184882 about?
NCT04184882 is a clinical study titled "A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)". The primary purpose of this study is to evaluate the safety and tolerability of ASP0367. This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle function of ASP0367.
What is the current status of trial NCT04184882?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-02-24. Estimated completion is 2022-09-04.
What interventions are being tested in trial NCT04184882?
The interventions under investigation include: Placebo (DRUG), Bocidelpar (DRUG).
Who is sponsoring clinical trial NCT04184882?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04184882's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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