Trials / Completed
CompletedNCT02531217
Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity, and Systemic Exposure of ATYR1940 in Adult Patients With Fascioscapulohumeral Muscular Dystrophy (FSHD)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- aTyr Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies.
Detailed description
The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies, and to additionally explore the pharmacokinetics and biologic activity of ATYR1940 in adult participants with molecularly defined genetic muscular dystrophies. Participants who successfully complete the parent study (NCT02239224) are eligible for enrollment into this long-term extension study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ATYR1940 | Concentrate for solution for infusion |
Timeline
- Start date
- 2015-08-13
- Primary completion
- 2016-05-26
- Completion
- 2016-05-26
- First posted
- 2015-08-24
- Last updated
- 2023-08-18
- Results posted
- 2023-08-18
Locations
3 sites across 3 countries: United States, Italy, Netherlands
Source: ClinicalTrials.gov record NCT02531217. Inclusion in this directory is not an endorsement.