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A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy
NCT06907875 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to learn how safe and tolerable EPI-321 is and whether there may be early signs it is working in male or female adult (18 to 75 years) participants with facioscapulohumeral muscular dystrophy (FSHD) Type 1 condition. The main questions it aims to answer are: How safe is EPI-321 and how well can people handle it over time? How does EPI-321 interact with its target and does it show early signs of working? Participants will receive a single dose of EPI-321 through a vein while being closely watched in a hospital and visit the clinic regularly for tests and checkups for about 5 years after getting EPI-321.
Conditions Studied
Interventions
- BIOLOGICAL EPI-321
Study Locations (7)
California
- David Geffen School of Medicine at University of California, Los Angeles — Los Angeles
Georgia
- Rare Disease Research — Atlanta
Maryland
- Kennedy Krieger Institute, Center for Genetic Muscle Disorders — Baltimore
Massachusetts
- University of Massachusetts Chan Medical School — Worcester
Utah
- Utah Program for Inherited Neuromuscular Disorders - University of Utah — Salt Lake City
New South Wales
- Royal Alfred Hospital — Sydney
Other
- Pacific Clinical Research Network — Auckland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-05-08 |
| Est. Completion | 2032-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06907875
The ClinicalTrials.gov registry entry for NCT06907875 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 Epicrispr Biotechnologies, which has 1 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 Facioscapulohumeral Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention — of which EPI-321 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: NCT06907875 reports 7 study locations spanning 7 distinct geographic areas — top geographies include California, Georgia, Maryland. 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 NCT06907875 about?
NCT06907875 is a clinical study titled "A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy". The goal of this clinical trial is to learn how safe and tolerable EPI-321 is and whether there may be early signs it is working in male or female adult (18 to 75 years) participants with facioscapulohumeral muscular dystrophy (FSHD) Type 1 condition. The main questions it aims to answer are: How s...
What is the current status of trial NCT06907875?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-05-08. Estimated completion is 2032-04-30.
What conditions does trial NCT06907875 study?
This clinical trial studies the following conditions: Facioscapulohumeral 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 NCT06907875?
The interventions under investigation include: EPI-321 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06907875?
This trial is sponsored by Epicrispr Biotechnologies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06907875 being conducted?
This trial has 7 study locations across California, Georgia, Maryland, Massachusetts, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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