A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease
NCT06858397 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-11-04
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
- Fabry Disesase
Interventions
- DRUG
-
HM15421/GC1134A
SC
Sponsors & Collaborators
-
Hanmi Pharmaceutical Company Limited
collaborator INDUSTRY -
GC Biopharma Corp
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-14
- Primary Completion
- 2028-08-30
- Completion
- 2028-08-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- South Korea
Study Locations
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