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Study of the Safety and Biologic Activity of AL01211 in Treatment Naive Males With Classic Fabry Disease

NCT06114329 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-07-30

No results posted yet for this study

Summary

This is a Phase II, open-label study designed to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of AL01211 in male subjects with classic Fabry disease who have never received any treatment (eg. ERT or chaperone therapy). Eligible subjects will receive 182 days (26 weeks) of study treatment as the primary study period followed by an extension period. The total study duration for a subject is up to at most 2 years including the primary period of 26 weeks.

Conditions

Interventions

DRUG

AL01211

AL01211 is a novel, proprietary, selective GCS inhibitor with high potency against GCS with limited off target activity.

Sponsors & Collaborators

  • AceLink Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nan Chen, Dr. · Ruijin Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06114329 on ClinicalTrials.gov