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RECRUITING 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)

NCT06817382 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 12 participants
Start Date 2025-07-22
Est. Completion 2028-03-31
Phase Phase 1

Sponsor

Insmed Gene Therapy

2 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insmed Gene Therapy, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06817382 reports 9 study locations spanning 7 distinct geographic areas — top geographies include California, Arkansas, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06817382?

The interventions under investigation include: INS1201 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06817382?

This trial is sponsored by Insmed Gene Therapy, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial