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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06858397 on ClinicalTrials.gov