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NCT06858397 · ClinicalTrials.gov registry record · Phase 1
A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease
A Phase 1 study of Fabry Disesase, sponsored by GC Biopharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 10
- Study locations
NCT06858397: Recruiting Phase 1 study of Fabry Disesase, sponsored by GC Biopharma.
NCT06858397 is a Phase 1 study of Fabry Disesase that is actively recruiting participants, run by GC Biopharma. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06858397, a Phase 1 study of Fabry Disesase, is actively recruiting participants, sponsored by GC Biopharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 10
- Study locations
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 Studied
Interventions
- DRUG HM15421/GC1134A
Study Locations (10)
Other
- Hospital Italiano de Buenos Aires - Buenos Aires
- Yonsei University, College of Medicine - Seoul
California
- David Geffen School of Medicine UCLA, UCLA Health - Los Angeles
Kansas
- University of Kansas School of Medicine - Kansas City
Minnesota
- University of Minnesota - Minneapolis
Ohio
- Children's Hospital Medical Center - Cincinnati
Pennsylvania
- University of Pittsburgh Medical Center Children's Hoispital of Pittsburgh - Pittsburgh
Virginia
- Lysosomal and Rare Disorders Research and Treatment Center - Fairfax
Santa Fe Province
- Centro Medico IPAM - Rosario
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2028-08-30 |
| Phase | Phase 1 |
What NCT06858397 shows while recruiting
NCT06858397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Fabry Disesase appearing as the primary indexed condition, and to 1 intervention - of which HM15421/GC1134A is the first listed.
NCT06858397 lists 10 locations in 9 states (Other, California, Kansas).
Frequently Asked Questions
What is clinical trial NCT06858397 about?
NCT06858397 is a clinical study titled "A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease". 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.
What is the current status of trial NCT06858397?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-05-14. Estimated completion is 2028-08-30.
What conditions does trial NCT06858397 study?
This clinical trial studies the following conditions: Fabry Disesase.
What interventions are being tested in trial NCT06858397?
The interventions under investigation include: HM15421/GC1134A (DRUG).
Who is sponsoring clinical trial NCT06858397?
This trial is sponsored by GC Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06858397 being conducted?
This trial has 10 study locations across California, Kansas, Minnesota, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06858397's enrollment target sits among peer trials
18 1721st of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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