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

NCT07085507 | Recruiting Phase 1

• 1 other identifier: VT7208-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

pharmacokinetics; healthy volunteers; pharmacodynamics; central nervous system

Outcome Measures

Primary Outcomes (3)

• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose.

  To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in healthy adults following a single dose.

  Up to 8 days

• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers who receive multiple daily doses.

  To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in healthy adults following multiple daily doses.

  Up to 16 days

• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of daily VT7208 in patients with MS

  To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with Multiple Sclerosis (MS).

  Up to 16 weeks

Secondary Outcomes (21)

• Pharmacokinetics of a single dose of VT7208-Cmax

  up to 8 days

• Pharmacokinetics of a single dose of VT7208-T 1/2

  up to 8 days

• Pharmacokinetics of a single dose of VT7208-Tmax

  up to 8 days

• Pharmacokinetics of a single dose of VT7208 fed state: Cmax

  up to 8 days

• Pharmacokinetics of a single dose of VT7208 fed state: T 1/2

  up to 8 days

Study Arms (6)

Part 1 SAD Cohorts: Active drug

EXPERIMENTAL

Participants will receive a single dose of VT7208 in a dose escalation format.

Drug: VT7208

Part 1 SAD Cohorts: Placebo

PLACEBO COMPARATOR

Healthy volunteers will receive a single dose of placebo

Drug: Placebo

Part 1 MAD Cohort: Active drug

EXPERIMENTAL

Healthy volunteers will receive repeated doses of VT7208. Dose to be determined based on escalation data from SAD Cohorts

Drug: VT7208

Part 1 MAD Cohort: Placebo

PLACEBO COMPARATOR

Healthy volunteers will receive repeated doses of placebo comparator.

Drug: Placebo

Part 2: Food Effect

EXPERIMENTAL

Open label randomized cohort to be administered to healthy volunteers. Participants will be randomized to receive dose in either fasted or fed state. Dose to be determined from data of SAD and MAD cohorts.

Drug: VT7208

Part 3: Patients with Multiple Sclerosis

EXPERIMENTAL

Open label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2.

Drug: VT7208

Interventions

VT7208 DRUG

a small synthetic molecule capsule, oral

Part 1 MAD Cohort: Active drug; Part 1 SAD Cohorts: Active drug; Part 2: Food Effect; Part 3: Patients with Multiple Sclerosis

Placebo DRUG

capsule, oral

Part 1 MAD Cohort: Placebo; Part 1 SAD Cohorts: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parts 1 and 2
• Age 18-65
• Must be in good health with no significant medical history
• Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
• Able and willing to provide written informed consent
• Part 3
• Age 18-60
• Must be in good health with no significant medical history
• MS diagnosis prior to Day 1 in accordance with 2017 McDonald criteria.
• Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
• Able and willing to provide written informed consent

You may not qualify if:

• Evidence of clinically significant condition or disease
• Any physical or psychological condition that prohibits study completion
• Known history of illicit drug use or drug abuse, harmful alcohol use (at the -Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 7 days prior to the first dose of study agent
• History of severe allergic reactions or hypersensitivity
• Donation or loss of ≥ 1 unit of whole blood or plasma within 4 weeks prior to dosing

Sponsors & Collaborators

• Vidya Therapeutics Inc: lead
• Vidya Therapeutics Australia Pty Ltd: collaborator

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

MIchele DeSciscio, MBSS

CONTACT

+61 (0) 422 447 902; Michele.DeSciscio@cmax.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

AU (1)