A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- GC Biopharma Corp
- Study ID
- NCT06858397
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Fabry Disesase
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- HM15421/GC1134A — DRUGSC
Study Details
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.
Key Dates
- Start date
- May 14, 2025
- Status verified
- Nov 2025
- Primary completion
- Aug 30, 2028
- Completion
- Aug 30, 2028
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1Low dose
- Experimental: Cohort 2Mid dose
- Experimental: Cohort 3High dose
Primary Outcome Measure
Incidences and characteristics of adverse events [ Time Frame: Up to 48 weeks ]
Central Contacts
- GC Biopharma+82-031-260-9300
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| David Geffen School of Medicine UCLA, UCLA Health | Los Angeles | California | 90095 | Anjay Rastogi, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas School of Medicine | Kansas City | Kansas | 66160-8500 | Ahmad M. Tuffaha, MD (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Chester B. Whitley, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | Robert J. Hopkin, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center Children's Hoispital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Damara Ortiz, MD (PRINCIPAL_INVESTIGATOR) |
| Lysosomal and Rare Disorders Research and Treatment Center | Fairfax | Virginia | 22030 | Ozlem Goker-Alpan, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Los Angeles, CA
By research site
David Geffen School of Medicine UCLA, UCLA Health· Los Angeles, CAUniversity of Kansas School of Medicine· Kansas City, KSUniversity of Minnesota· Minneapolis, MNChildren's Hospital Medical Center· Cincinnati, OHUniversity of Pittsburgh Medical Center Children's Hoispital of Pittsburgh· Pittsburgh, PALysosomal and Rare Disorders Research and Treatment Center· Fairfax, VA