Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07085507

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

Led by Vidya Therapeutics Inc · Updated on 2025-09-03

100

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

V

Vidya Therapeutics Inc

Lead Sponsor

V

Vidya Therapeutics Australia Pty Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years for Parts 1 and 2
  • Age 18 to 60 years for Part 3
  • Good health with no significant medical history
  • Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for cerebrospinal fluid collection
  • Able and willing to provide written informed consent
  • For Part 3, diagnosed with multiple sclerosis before Day 1 according to 2017 McDonald criteria
Not Eligible

You will not qualify if you...

  • Evidence of any clinically significant condition or disease
  • Any physical or psychological condition that would prevent completing the study
  • History of illicit drug use or drug abuse, harmful alcohol use, alcoholism, and/or use of smoking or nicotine products within 7 days before first dose
  • History of severe allergic reactions or hypersensitivity
  • Donation or loss of one or more units of whole blood or plasma within 4 weeks before dosing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CMAX

Adelaide, South Australia, Australia, 5000

Actively Recruiting

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Research Team

M

MIchele DeSciscio, MBSS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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