A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R08b in Parkinson's Disease Patients With GBA1 Mutations
NCT07414290 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2026-05-01
Summary
A Phase I/II Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-R08b Intra-cerebroventricular injection in Parkinson's Disease Patients with GBA1 Mutations
Conditions
- Parkinson Disease (PD)
Interventions
- DRUG
-
VGN-R08b 4.2×10^13 vg
Intracerebroventricular injection
- DRUG
-
VGN-R08b 8.4×10^13 vg
Intracerebroventricular injection
- DRUG
-
VGN-R08b 1.68×10^14 vg
Intracerebroventricular injection
Sponsors & Collaborators
-
Shanghai Vitalgen BioPharma Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-25
- Primary Completion
- 2027-09-01
- Completion
- 2031-09-01
Countries
- China
Study Locations
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