Actively Recruiting
Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
Led by Innopeutics Corporation · Updated on 2026-04-21
6
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease meeting UK Brain Bank Clinical Criteria
- Male or female aged 50 to 80 years with documented Parkinson's disease
- Parkinson's disease duration of at least 10 years
- Parkinson's disease symptoms inadequately controlled despite all available standard treatments
- Hoehn & Yahr stage 4 or 5 in the off medication state at screening
You will not qualify if you...
- Diagnosis of Parkinson's disease dementia as per Movement Disorder Society criteria
- Korean Mini-Mental State Examination score 24 or lower
- Imaging suggesting Parkinsonism-plus syndrome on PET or MRI
- Major visual hallucinations without dementia diagnosis
- Drug-induced parkinsonism confirmed by history or records
- Investigator judgment of unsuitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
C
ChoLong Park
CONTACT
T
Tae-gyun Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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