RECRUITING

A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy

Description

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.

Study Overview

Study Details

Study overview

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.

A Phase 1/2 Open-label Dose-escalation Study to Evaluate the Safety, Tolerability, and Biological Activity of EPI-321, an AAVrh74-delivered Epigenetic Editing Therapy in Adult FSHD Patients

A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy

Condition
Facioscapulohumeral Muscular Dystrophy
Intervention / Treatment

-

Contacts and Locations

Atlanta

Rare Disease Research, Atlanta, Georgia, United States, 303329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Able and willing to provide informed consent
  • * Male or female 18 to 75 years of age
  • * Clinical diagnosis of FSHD with genetic Type 1
  • * FSHD Ricci clinical severity score 2 to 4 (on 5-point scale)
  • * Has adequate liver function
  • * Has adequate kidney function
  • * Has an anti-AAVrh74 total binding antibody titer \> 1:400
  • * Requires a walker or wheelchair for ambulation
  • * Pregnant and/or breastfeeding at baseline or is planning to become pregnant during the first 12 months following EPI-321 administration
  • * Has FSHD Type 2
  • * Has a body mass \>90 kg
  • * Has a concurrent or past medical conditions could jeopardize the safety of the participant

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Epicrispr Biotechnologies, Inc.,

Study Record Dates

2032-04-30