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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

NCT07685444 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

  • Parkinson's Disease (PD)

Interventions

GENETIC

LY-N001 Injection

LY-N001 Injection shall be administered as a single intracerebroventricular (ICV) injection, with one administration only

Sponsors & Collaborators

  • Lingyi Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yi Wang, PhD · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-07
Primary Completion
2028-07-07
Completion
2032-12-30

Countries

  • China

Study Locations

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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 NCT07685444 on ClinicalTrials.gov