A Study on the Safety and Tolerability of RGL-193 in Patients With Advanced Parkinson's Disease

Early Phase 1

Recruiting

• Conditions: Advanced Parkinson's Disease
• Interventions: Drug: RGL-193（low-dose）; Drug: RGL-193（high-dose）

• Registration Number: NCT06195124
• Lead Sponsor: Second Affiliated Hospital of Soochow University

Brief Summary

A safety study in patients with Parkinson's disease.

Detailed Description

This is an open-label, dose-escalation safety and tolerability study in patients with advanced Parkinson's disease

Study Timeline

• Study First Submitted: 2023-10-14
• Study Start: 2023-12
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RGL-193（low-dose）Treatment group	RGL-193（low-dose）	Each side of the putamen received 150 μL of RGL-193, with a unilateral dose of 1.5×10\^11 VG and a bilateral dose of 3.0×10\^11 VG.
RGL-193（high-dose）Treatment group	RGL-193（high-dose）	Each side of the putamen received 200 μL of RGL-193, with a unilateral dose of 5.0×10\^11 VG and a bilateral dose of 1.0×10\^12 VG.

Primary Outcome Measures

Name	Time	Method
the number of patients with clinically significant change from baseline in laboratory examination	26 weeks after administration
the number of patients with clinically significant change in physical examination	26 weeks after administration
the number of patients with adverse events	26 weeks after administration
the number of patients with clinically significant change from baseline in vital signs value	26 weeks after administration
the number of patients with clinically significant change from baseline in 12-ECG values	26 weeks after administration
the number of patients with clinically significant change in brain MRI	26 weeks after administration

Trial Locations

Locations (1)

Department of Neurology, Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China