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drugset / Trial / NCT07414290

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

NCT07414290 ↗

Phase 1/2 Not yet recruiting 17 enrolled Shanghai Vitalgen BioPharma Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2026-05-25
Primary completion
2027-09-01
Completion
2031-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject VGN-R08b Gene therapy (AAV / viral vector) 4.2e+13 vg Other
Subject VGN-R08b Gene therapy (AAV / viral vector) 8.4e+13 vg Other
Subject VGN-R08b Gene therapy (AAV / viral vector) 1.68e+14 vg Other

Indications

Parkinson disease