Trials / Recruiting
RecruitingNCT06858397
A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease
An Open Label, Dose Range, Proof-of-Concept Study to Assess the Safety and Efficacy of HM15421/GC1134A in Patients With Fabry Disease
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- GC Biopharma Corp · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 1/2 first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15421 in patients with FD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HM15421/GC1134A | SC |
Timeline
- Start date
- 2025-05-14
- Primary completion
- 2028-08-30
- Completion
- 2028-08-30
- First posted
- 2025-03-05
- Last updated
- 2025-11-04
Locations
10 sites across 3 countries: United States, Argentina, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06858397. Inclusion in this directory is not an endorsement.