Phase 2a Study of VTX3232 in Parkinson's Disease

Phase 2

Completed

• Conditions: Idiopathic Parkinson Disease
• Interventions: Drug: VTX3232

• 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

Study Timeline

• Study Start: 2024-08-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-15
• Primary Completion: 2025-04-04
• Study Completion: 2025-04-04
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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