Clinical Trial

A Study of the Safety and Preliminary Efficacy of LY-M001 Injection in the Treatment of Adult Patients With Gaucher Disease Type I

Study acronym: LY-M001
Recruiting
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Summary
This is a prospective single-center, open, single-arm, single-dose intravenous infusion study to evaluate the safety and initial efficacy, pharmacodynamic characteristics, immunogenicity, biodistribution, and viral shedding of LY-M001 injection.This study mainly includes the main study stage and the long-term follow-up study stage.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-11-30.
Trial Details
NCT Number NCT06162338
Lead Sponsor He Huang
Collaborators: Lingyi Biotech Co., Ltd.
Conditions Gaucher Disease Type I
Enrollment 3 participants
Start Date 2023-11-15
Primary Completion 2026-12-17 (estimated)
Study Completion 2031-12-17 (estimated)
Updated on ClinicalTrials.gov 2025-02-14