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

Condition(s) studied

Investigational drug(s) / intervention(s)

IPS101A: The investigational product (IP) will be administered as a single dose. All subjects will receive stereotactic injections into the left and right substantia nigra of the midbrain, with one administration per side.

Study 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.

Eligibility

Primary outcome measure(s)

• Safety Evaluation: dose-limiting toxicity (DLT) — Baseline to Week 8
  Frequency and proportion of subjects who developed dose-limiting toxicity (DLT)
• Safety Evaluation: Severity and frequency of reported adverse events — Baseline to Week 52
  Assess severity and frequency of reported adverse events
• Safety Evaluation: clinically-relevant changes in laboratory testing assessed by medical personnel — Baseline to Week 52
  The clinical significance of laboratory test results after administration of a clinical trial drug is confirmed by comparing them with those before administration.
• Safety Evaluation: clinically-relevant changes in physical exams assessed by medical personnel — Baseline to Week 52
  The results of the physical examination after administration of the clinical trial drug are compared with those before administration to determine whether clinically significant symptoms occur.

Trial sites (1)

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