Phase 2a Study of VTX3232 in Parkinson's Disease
- Registration Number
- NCT06556173
- Lead Sponsor
- Zomagen Biosciences Ltd.
- Brief Summary
This is a study to understand if taking VTX3232 is safe in participants diagnosed with early stage idiopathic Parkinson's Disease (PD). Approximately 10 patients will take VTX3232 Dose A.
The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 7-day Pre-Baseline Period, a 28-day Open Label Treatment period (a participant receives active Dose A), and a 14-day Follow-Up Period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Participants must be ≥ 40 years up to 80 years of age, inclusive, at the time of signing the informed consent, with BMI > 18.5 and < 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Diagnosis of idiopathic Parkinson's Disease between 0 and 60 months prior to screening.
- Score of 2 or less on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV at screening.
- Have not received prior treatment with deep brain stimulation (DBS).
- If receiving treatment with symptomatic PD therapies, treatment must be stable. Note: The Medical Monitor should be contacted with any questions regarding concomitant therapies.
- A female participant is eligible if they are of nonchildbearing potential
- A male participant sexually active with a woman of child bearing potential is eligible if they agree to use contraception/barrier and refrain from donating sperm during the study and for at least 90 days after the last dose
Exclusion Criteria
- Diagnosis of a Parkinsonian syndrome other than idiopathic Parkinson's Disease.
- A diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease; history of repeated head injury or traumatic brain injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
- History of brain surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VTX3232 Dose A VTX3232 -
- Primary Outcome Measures
Name Time Method Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion Day 1 of treatment period through study completion, up to 6 weeks Incidence of AEs and SAEs
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) of VTX3232 in plasma and Cerebrospinal Fluid (CSF) at Day 28 Day 1 of treatment period to Day 28 of treatment period Concentration of VTX3232 in plasma and CSF through 28 days of study treatment
Trial Locations
- Locations (1)
Local Site #840001
🇺🇸New Haven, Connecticut, United States