NCT06480461

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Shanghai Vitalgen BioPharma Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

In the open-label dose escalation part, 3 dose cohorts will be explored, with 3 subjects per cohort. Cohort 1: 3 subjects on 8.0×10\^11 vg for at least 4 weeks post infusion Cohort 2: 3 subjects on 1.6×10\^12 vg for at least 4 weeks post infusion Cohort 3: 3 subjects on 3.2×10\^12 vg for at least 4 weeks post infusion In the dose-escalation part, each cohort follows the principle of sentinel administration (i.e., one subject will be enrolled and dosed first in each cohort). If no significant safety risk is observed within 4 weeks after administra-tion, the remaining 2 subjects will be dosed. Additional cohort(s) and/or a safe low and high dose will be determined by the safety review committee (SRC) to initiate Part II

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-02
• Primary completion: 2026-09-10
• Completion: 2030-09-10
• First posted: 2024-06-28
• Last updated: 2026-03-31

Locations

1 site across 1 country: China