RecruitingPhase 1Phase 2NCT07085507

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208 in Healthy Participants and MS Patients

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study in Healthy Participants and an Expansion Cohort in Adult Patients With Multiple Sclerosis to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208


Sponsor

Vidya Therapeutics Inc

Enrollment

100 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Part 1 of this study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VT7208 in healthy volunteers. Part 2 of this study will be an open-label, randomized study to characterize the effect of food on the pharmacokinetics of VT7208 in healthy volunteers. Part 3 of this study will evaluate the safety of VT7208 as monotherapy in patients with MS.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and how the body processes a new experimental drug called VT7208, which is being investigated as a potential treatment for multiple sclerosis (MS). Healthy volunteers are tested first, then people with MS. Some participants will have spinal fluid collected via a spinal tap (lumbar puncture). **You may be eligible if...** - You are between 18 and 65 years old (healthy volunteers), or 18 to 60 years old (MS patients) - You are generally in good health with no significant medical history - If you have MS: your diagnosis meets the 2017 McDonald criteria - You are willing to attend all visits and undergo a spinal tap for cerebrospinal fluid collection **You may NOT be eligible if...** - You have clinically significant conditions that could interfere with the study - You have physical or mental health conditions preventing study completion - You have relevant drug allergies or other serious health issues 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

DRUGVT7208

a small synthetic molecule capsule, oral

DRUGPlacebo

capsule, oral


Locations(1)

CMAX

Adelaide, South Australia, Australia

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NCT07085507


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