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A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R08b in Parkinson's Disease Patients With GBA1 Mutations

StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Notable Start date: Mar 1, 2026 to May 25, 2026v3
  2. Minor Interventions: VGN-R08b (Drug), VGN-R08b (Drug), VGN-R08b (Drug) to VGN-R08b 1.68×10^14 vg (Drug), VGN-R08b 4.2×10^13 vg (Drug), VGN-R08b 8.4×10^13 vg (Drug)
    • Secondary endpoints: 1 to 6
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07414290
Lead Sponsor Shanghai Vitalgen BioPharma Co., Ltd.
Conditions
(from sponsor)
Parkinson Disease (PD)
Related terms Parkinson Disease
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov