NCT07085507

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vidya Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a Phase 1/2 randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants. Following completion of SAD and MAD cohorts, healthy volunteers will participate in administration of VT7208 with and without food to determine the effect of a fasted or fed state on pharmacokinetics. Participants with MS will be recruited for part 3 of this study. This study consists of 3 parts, as follows: Part 1: SAD in healthy volunteers with a single dose administration of VT7208 or placebo and collection of study data. MAD in healthy volunteers with multiple dose administration of VT7208 or placebo and collection of study data. Part 2: Food effect cohort in healthy volunteers. Participants will be randomized to receive open label VT7208 in either a fasted state or a fed state, and will receive the opposite at the next admission to the study site. Part 3: Participants MS will receive VT7208 with dose determined from Parts 1 and 2. Participation in this section will entail weekly study visits for administration of study medication collection of study data.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	VT7208	a small synthetic molecule capsule, oral
DRUG	Placebo	capsule, oral

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-10-30
• Completion: 2027-12-31
• First posted: 2025-07-25
• Last updated: 2025-09-03

Locations

1 site across 1 country: Australia