RecruitingPhase 1NCT07310264

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

A Phase I, Randomized, Single Ascending Dose, Multiple Ascending Dose, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AX-5006 (Aka VT-5006) in Healthy Participants and Participants With Parkinson's Disease.


Sponsor

Vertero Therapeutics

Enrollment

84 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental drug called VT-5006, which is being investigated as a potential treatment for Parkinson's disease. Early phases test it in healthy volunteers; a later phase (Part C) specifically focuses on people with Parkinson's who also have digestive/gut problems. **You may be eligible if...** - You have had a neurologist-confirmed Parkinson's disease diagnosis within the past 10 years - You have a history of gut motility issues or persistent constipation - You are able to swallow large capsules - Your current Parkinson's medications are at a stable dose **You may NOT be eligible if...** - You have had recent changes in your Parkinson's medications - You have conditions that would interact with the study drug - You do not have gut problems related to your Parkinson's Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVT-5006

Oral Capsules, Active

DRUGPlacebo

Oral Capsules, Matched Placebo


Locations(1)

Center for Human Drug Research

Leiden, Netherlands

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NCT07310264


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