Actively Recruiting
Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease
Led by Vertero Therapeutics · Updated on 2026-03-20
84
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C). Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights. Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit. Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.
CONDITIONS
Official Title
Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Parkinson's disease confirmed by a neurologist within 10 years prior to screening
- Has current or history of gastrointestinal motility dysfunction or persistent constipation
- Score less than 3 on the Modified Hoehn and Yahr Scale
- Able to swallow multiple large capsules without assistance or difficulty
- On a stable regimen of prescribed (except levodopa/carbidopa, levodopa/benserazide, or anticholinergic agents) or over-the-counter medications or supplements for at least 60 days prior to enrollment
- Has suitable venous access for blood sampling
You will not qualify if you...
- Known allergy or severe hypersensitivity to any component of VT-5006 or placebo
- Taking levodopa/carbidopa or levodopa/benserazide with unstable dose or regimen less than 21 days before Day 1 visit
- Clinically significant arrhythmia with corrected QT interval above 450 ms for males or 470 ms for females
- Significant abnormalities in laboratory tests including liver and kidney panels, blood counts, chemistry, or urinalysis
- Serum total bilirubin greater than 1.5 times upper limit of normal
- Serum ALT or AST levels twice the upper limit of normal, except Gilbert's syndrome with non-significant bilirubin elevation
- History of lumbar surgery that may interfere with or pose risks to lumbar puncture
- Other contraindications to lumbar puncture
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for Human Drug Research
Leiden, Netherlands
Actively Recruiting
Research Team
P
P.H.C. Kremer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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