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Active, not recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT06817382

Public ClinicalTrials.gov record NCT06817382. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 17, 2026, 10:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Multicenter, Open-label Study to Investigate the Safety and Biodistribution of a Single Intrathecal Injection of INS1201 in Ambulatory Males With Duchenne Muscular Dystrophy (The ASCEND Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06817382
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Insmed Gene Therapy LLC
Industry
Enrollment
12 participants

Conditions and interventions

Interventions

Genetic

Eligibility (public fields only)

Age range
2 Years to 4 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 21, 2025
Primary completion
Jan 30, 2028
Completion
Mar 30, 2028
Last update posted
Sep 15, 2026

2025 – 2028

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
USA012 Little Rock Arkansas 72202
USA010 Davis California 95616
USA009 Los Angeles California 90095
USA002 Palo Alto California 94070
USA005 San Diego California 93123
Rare Disease Research (USA004) Atlanta Georgia 30329
USA008 Rochester New York 14642
USA006 Columbus Ohio 43205
USA001 Memphis Tennessee 38105
USA015 Norfolk Virginia 23507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06817382, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 15, 2026 · Synced Sep 17, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06817382 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →