NCT05882487

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

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
GENETIC	KL002 injection solution	Neurosurgical delivery of KL002 to the brain

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

1 site across 1 country: China