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drugset / Trial / NCT07371338

Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients

NCT07371338 ↗

Phase 1 Recruiting 6 enrolled Innopeutics Corporation
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the dose-related safety and tolerability of IPS101A, an adeno-associated virus (AAV) gene therapy, in patients with Parkinson's disease who exhibit severe functional impairment corresponding to Hoehn \& Yahr stages 4-5 and whose symptoms are not adequately controlled despite all available monotherapy and combination therapy options. In addition, the study aims to assess the maximum tolerated dose (MTD) of IPS101A, as well as its preliminary efficacy and pharmacokinetic (PK) characteristics.

Timeline

Start
2026-05-30
Primary completion
2027-10-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject IPS101A Gene therapy (AAV / viral vector) 1e+10 vg Other
Subject IPS101A Gene therapy (AAV / viral vector) 2e+10 vg Other

Indications

Parkinson disease