Phase 2a Study of VTX3232 in Parkinson's Disease

Last updated: July 15, 2025
Sponsor: Zomagen Biosciences Ltd.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

VTX3232

Clinical Study ID

NCT06556173
VTX3232-203
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be ≥ 40 years up to 80 years of age, inclusive, at the time ofsigning 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 toscreening.

  • Score of 2 or less on Movement Disorder Society-Unified Parkinson's Disease RatingScale (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 regardingconcomitant therapies.

  • A female participant is eligible if they are of nonchildbearing potential

  • A male participant sexually active with a woman of child bearing potential iseligible if they agree to use contraception/barrier and refrain from donating spermduring the study and for at least 90 days after the last dose

Exclusion

Exclusion Criteria:

  • Diagnosis of a Parkinsonian syndrome other than idiopathic Parkinson's Disease.

  • A diagnosis of a significant central nervous system (CNS) disease other thanParkinson'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

Total Participants: 11
Treatment Group(s): 1
Primary Treatment: VTX3232
Phase: 2
Study Start date:
August 08, 2024
Estimated Completion Date:
April 04, 2025

Connect with a study center

  • Local Site #840001

    New Haven, Connecticut 06510
    United States

    Site Not Available

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