Clinical Trial

A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Males With Duchenne Muscular Dystrophy (DMD)

Study acronym: ASCEND
Recruiting Phase 1
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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.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2025-02-04; most recent amendment 2026-07-27.
Status change: Not Yet Recruiting → Recruiting 2025-04-10
Trial Details
NCT Number NCT06817382
Lead Sponsor Insmed Gene Therapy LLC
Conditions Duchenne Muscular Dystrophy
Enrollment 12 participants
Start Date 2025-07-22
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28