Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary PD

Parkinson Disease Clinical Trial

Official title: Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary Parkinson's Dissease

Status Not yet recruiting

Clinical Trial Summary

This is a non-randomized, open label, dose-escalation study to evaluate the safety and efficacy of KL002 in the treatment of advanced primary Parkinson's disease.

Condition or disease: Parkinson's Disease Intervention/treatment: Drug: KL002 Phase: NA

Clinical Trial Description

9 patients will be enrolled to this open-label dose escalation study to evaluate up to three dose levels of KL002 of three patients each. All patients will receive bilateral intraputaminal injections of KL002 through stereotactic brain surgery. The safety and potential clinical responses to KL002 will be assessed by clinical evaluations of Parkinson's disease, cognitive tests, laboratory blood tests and neuroimaging. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05882487
• Study type: Interventional
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yang Ruan, M.D.
• Phone: +86 18858736151
• Email: 11818236@zju.edu.cn
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2023
• Completion date: June 30, 2026