Testing VTX3232 for early stage Parkinson's Disease
A Phase 2a, Single Site, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTX3232 in Participants with Early-Stage Parkinson's Disease
PHASE2 · Zomagen Biosciences Ltd. · NCT06556173
This study is testing a new drug called VTX3232 to see if it is safe and helpful for people with early stage Parkinson's Disease.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Zomagen Biosciences Ltd. (industry) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06556173 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of VTX3232 in patients diagnosed with early stage idiopathic Parkinson's Disease. It involves a 30-day screening period to determine eligibility, followed by a 7-day pre-baseline period, a 28-day open-label treatment phase where participants receive active Dose A of VTX3232, and a 14-day follow-up period. Approximately 10 patients will be enrolled to assess the drug's effects and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 80 with a recent diagnosis of idiopathic Parkinson's Disease and stable treatment.
Not a fit: Patients who have received deep brain stimulation or have severe Parkinson's symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing early stage Parkinson's Disease.
How similar studies have performed: While this approach is novel, similar studies targeting NLRP3 inhibition in neurodegenerative diseases have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Haven, Connecticut
- Local Site #840001 — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Study coordinator: Ventyx Clinical Trial Contact
- Email: ClinicalTrials@ventyxbio.com
- Phone: 888-411-5176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Idiopathic Parkinson Disease, VTX3232, Idiopathic Parkinson's Disease, NLRP3 Inhibitor, Zomagen