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NCT06817382 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Males With Duchenne Muscular Dystrophy (DMD)
A Phase 1 study of Duchenne Muscular Dystrophy, sponsored by Insmed Gene Therapy.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 9
- Study locations
NCT06817382: Recruiting Phase 1 study of Duchenne Muscular Dystrophy, sponsored by Insmed Gene Therapy.
NCT06817382 is a Phase 1 study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Insmed Gene Therapy. The registered enrollment target is 12 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06817382, a Phase 1 study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Insmed Gene Therapy.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 9
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of a single dose of INS1201 via IT administration in ambulatory male participants with DMD.
Conditions Studied
Interventions
- GENETIC INS1201
Study Locations (9)
California
- USA010 - Davis
- USA002 - Palo Alto
- USA005 - San Diego
Arkansas
- USA012 - Little Rock
Georgia
- Rare Disease Research (USA004) - Atlanta
New York
- USA008 - Rochester
Ohio
- USA006 - Columbus
Tennessee
- USA001 - Memphis
Virginia
- USA015 - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 1 |
What NCT06817382 shows while recruiting
NCT06817382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which INS1201 is the first listed.
NCT06817382 lists 9 locations in 7 states (California, Arkansas, Georgia).
Frequently Asked Questions
What is clinical trial NCT06817382 about?
NCT06817382 is a clinical study titled "A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Males With Duchenne Muscular Dystrophy (DMD)". The primary objective of this study is to evaluate the safety and tolerability of a single dose of INS1201 via IT administration in ambulatory male participants with DMD.
What is the current status of trial NCT06817382?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-07-22. Estimated completion is 2028-03-31.
What conditions does trial NCT06817382 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT06817382?
The interventions under investigation include: INS1201 (GENETIC).
Who is sponsoring clinical trial NCT06817382?
This trial is sponsored by Insmed Gene Therapy, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06817382 being conducted?
This trial has 9 study locations across Arkansas, California, Georgia, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Duchenne Muscular Dystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06817382's enrollment target sits among peer trials
12 41st of 48 higher than 7 of 48 other Duchenne Muscular Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy 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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-
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Study of AOC 1044 in Healthy Adult Volunteers and Participants With Duchenne Muscular Dystrophy (DMD) Mutations Amenable to Exon 44 Skipping
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