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RECRUITING Phase 1

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

NCT06858397 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 18 participants
Start Date 2025-05-14
Est. Completion 2028-08-30
Phase Phase 1

Sponsor

GC Biopharma

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06858397

The ClinicalTrials.gov registry entry for NCT06858397 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GC Biopharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06858397 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06858397?

The interventions under investigation include: HM15421/GC1134A (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06858397?

This trial is sponsored by GC Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial