Idiopathic Parkinson Disease
Conditions
Keywords
VTX3232, Idiopathic Parkinson's Disease, NLRP3 Inhibitor, Zomagen
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.
Interventions
DRUGVTX3232
Dose A
Sponsors
Zomagen Biosciences Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORSnehal Naik, PhD
Zomagen Biosciences Ltd.
Outcome results
None listed