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HM15421/GC1134A for Fabry Disease

This study is testing a new medication called HM15421/GC1134A for people with Fabry Disease. Researchers want to see how safe it is, if your body can handle it well (tolerability), and how it moves through your body (pharmacokinetics). They also want to see if it helps with your Fabry Disease symptoms. You can join if you are 18 or older and have a confirmed diagnosis of Fabry Disease with symptoms. For women, a genetic test showing a specific change in the GLA gene is needed. The main goal is to track any side effects over 48 weeks. This study is currently recruiting about 18 participants.

Study design
This is a Phase 1/2 study, which means it's one of the first times this drug is being tested in humans. It will include about 18 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track side effects for up to 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06858397

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
GC Biopharma Corp
~18 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:HM15421/GC1134A

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidences and characteristics of adverse events
Measured over Up to 48 weeks

Conditions

Fabry Disesase

Explore related trials

Fabry DiseaseAlpha-galactosidaseGALACTOSIDASE, ALPHAglobotriaosyl lysosphingolipid

Where it's being run

10 sites across 10 states
California1
Kansas1
Minnesota1
Ohio1
Pennsylvania1
Virginia1
Santa Fe Province1
Argentina1

Who to contact

GC Biopharma
[email protected]
+82-031-260-9300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male participants are eligible to participate if they agree to the following during the study treatment period:
Refrain from donating sperm,
Be abstinent from heterosexual intercourse with a woman of childbearing potential (WOCBP) as their preferred and usual lifestyle (abstinent on a longterm and persistent basis) and agree to remain abstinent, OR
Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,
In addition to male condom, use of highly effective method of contraception may be considered in WOCBP partners of male participants. 9. Female participants:
Female participants are eligible to participate if they are not pregnant or breastfeeding, and at least 1 of the following conditions applies:
Is not a WOCBP, OR
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year), preferably with low user dependency, starting at least one menstrual cycle before first study drug administration and continuing for at least 30 days after the end of systemic exposure of the study drug and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study drug.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study drug.
If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Women whose postmenopausal status is recent, may perform additional follicle stimulating hormone (FSH) testing.

What this trial measures

  • Incidences and characteristics of adverse eventsUp to 48 weeks