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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06817382
The ClinicalTrials.gov registry entry for NCT06817382 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (97% lower). The listed sponsor is Insmed Gene Therapy, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 7 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.