drugset / Trial / NCT07085195

A Clinical Study of the Safety and Efficacy of Chemogenetics Therapy in the Treatment of Parkinson's Disease

NCT07085195

Phase 0 Not yet recruiting 6 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

Summary

The investigators propose a gene therapy strategy using chemical genetic inhibition to intervene in the abnormal activity of the subthalamic nucleus in Parkinson's disease. The investigators design and construct a highly efficient therapeutic injection STP-001 (first drug), through the efficient adeno-associated virus capsid (AAV), neuronal promoter (hSyn), and chemical genetic effector element (hM4Di), and accurately inject the drug into the bilateral subthalamic nucleus, the core pathological nucleus of Parkinson's disease, through stereotactic technology. Combined with a very low dose of clozapine (the second drug), the abnormal activity of the subthalamic nucleus is precisely intervened to improve the core motor symptoms of Parkinson's disease.

Timeline

Start
2025-08-01
Primary completion
2025-12-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject STP-001 Gene therapy (AAV / viral vector) 1e+12 vg Other
Subject STP-001 Gene therapy (AAV / viral vector) 2e+12 vg Other
Subject STP-001 Gene therapy (AAV / viral vector) 4e+12 vg Other
Background Clozapine Other / unclassified 3.125 mg Oral

Indications