Clinical Trial

A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease

Recruiting Phase 1/2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-02-27; most recent amendment 2025-11-02.
Status change: Not Yet Recruiting → Recruiting 2025-06-17
Trial Details
NCT Number NCT06858397
Lead Sponsor GC Biopharma Corp
Collaborators: Hanmi Pharmaceutical Company Limited
Conditions Fabry Disesase
Enrollment 18 participants
Start Date 2025-05-14
Primary Completion 2028-08-30 (estimated)
Study Completion 2028-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-04