Clinical Trial

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Intracerebral Injection of LY-N001 Injection for the Treatment of Moderate to Advanced Parkinson's Disease With GBA1 Mutations

Not Yet Recruiting Early Phase 1
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Summary
This is a prospective, single-arm, single-dose clinical study designed to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of LY-N001 Injection in patients with moderate-to-advanced Parkinson's disease carrying GBA1 mutations. The study consists of a main study phase and a long-term follow-up phase.
Trial Details
NCT Number NCT07685444
Lead Sponsor Lingyi Biotech Co., Ltd.
Conditions Parkinson's Disease (PD)
Enrollment 18 participants
Start Date 2026-07-07
Primary Completion 2028-07-07 (estimated)
Study Completion 2032-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-06