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NCT06907875 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy
A Phase 1 study of Facioscapulohumeral Muscular Dystrophy, sponsored by Epicrispr Biotechnologies.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 7
- Study locations
NCT06907875: Recruiting Phase 1 study of Facioscapulohumeral Muscular Dystrophy, sponsored by Epicrispr Biotechnologies.
NCT06907875 is a Phase 1 study of Facioscapulohumeral Muscular Dystrophy that is actively recruiting participants, run by Epicrispr Biotechnologies. The registered enrollment target is 12 participants, below the 1,510-participant average among 6 other Facioscapulohumeral Muscular Dystrophy trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06907875, a Phase 1 study of Facioscapulohumeral Muscular Dystrophy, is actively recruiting participants, sponsored by Epicrispr Biotechnologies.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
All AEs, regardless of assessed relatedness to EPI-321, will be collected from the time of informed consent signature until the end of study participation. The Investigator is responsible for assessing the severity of an AE according to the NCI-CTCAE version 5.0.
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 |
What NCT06907875 shows while recruiting
NCT06907875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,510-participant average among 6 other Facioscapulohumeral Muscular Dystrophy trials with a reported enrollment target (99% lower).
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.
NCT06907875 lists 7 locations in 7 states (California, Georgia, Maryland).
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.
What interventions are being tested in trial NCT06907875?
The interventions under investigation include: EPI-321 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06907875?
This trial is sponsored by Epicrispr Biotechnologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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