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ACTIVE NOT RECRUITING
NCT06480461
PHASE1/PHASE2

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Patients With Parkinson's Disease

Sponsor: Shanghai Vitalgen BioPharma Co., Ltd.

View on ClinicalTrials.gov

Summary

A phase Ⅰ/Ⅱ study to evaluate the tolerability, safety, and efficacy of VGN-R09b in pa-tients with Parkinson's disease

Official title: A Phase Ⅰb/Ⅱ Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-R09b in Patients With Parkinson's Disease

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2024-09-02

Completion Date

2030-09-10

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

VGN-R09b

This is a Phase I/II trial, with safety as the primary measure. Sample size is not determined through statistical justification. There will be 3 subjects in each dose cohort in the dose escalation part. In the dose expansion part, a sham surgery group and 2 dose groups will be designed; 10 subjects will be enrolled in each group.

Locations (1)

Shanghai

Shanghai, Shanghai Municipality, China