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NCT Number: NCT07085507

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

This study is a Phase 1/2 randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy volunteers.

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 and collection of study data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

VT7208

Drug

a small synthetic molecule capsule, oral

Placebo

Drug

capsule, oral

Primary outcomes

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

    Time frame: Up to 8 days

    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.

  2. 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.

    Time frame: Up to 16 days

    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.

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

    Time frame: Up to 16 weeks

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

Secondary outcomes

  1. Pharmacokinetics of a single dose of VT7208-Cmax

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose

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

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50%

  3. Pharmacokinetics of a single dose of VT7208-Tmax

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin.

  4. Pharmacokinetics of a single dose of VT7208 fed state: Cmax

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fed state. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose

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

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy adults in a fed state. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50%

  6. Pharmacokinetics of a single dose of VT7208 fed state: Tmax

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fed state. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin.

  7. Pharmacokinetics of a single dose of VT7208 fasted state: Cmax

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fasted state. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose

  8. Pharmacokinetics of a single dose of VT7208 fasted state: T 1/2

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy adults in a fasted state. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50%

  9. Pharmacokinetics of a single dose of VT7208 fasted state: Tmax

    Time frame: up to 8 days

    PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fasted state. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin.

  10. Pharmacokinetics of a multiple doses of VT7208-Cmax

    Time frame: up to 16 days

    PK parameters of VT7208 on concentrations in plasma following multiple doses in healthy volunteers. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose

  11. Pharmacokinetics of a multiple doses of VT7208-T 1/2

    Time frame: up to 16 days

    PK parameters of VT7208 on concentrations in plasma following multiple doses in healthy volunteers. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50%

  12. Pharmacokinetics of a multiple doses of VT7208-T max

    Time frame: up to 16 days

    PK parameters of VT7208 on concentrations in plasma following multiple doses in healthy volunteers. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin.

  13. Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-Cmax

    Time frame: up to 16 weeks

    PK parameters of VT7208 on concentrations in plasma in participants with Multiple Sclerosis (MS). Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose

  14. Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-T 1/2

    Time frame: up to 16 weeks

    PK parameters of VT7208 on concentrations in plasma in participants with Multiple Sclerosis (MS). T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50%

  15. Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-Tmax

    Time frame: up to 16 weeks

    PK parameters of VT7208 on concentrations in plasma in participants with Multiple Sclerosis (MS). Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin.

  16. Pharmacodynamics of a single dose of VT7208 in healthy volunteers

    Time frame: up to 8 days

    Pharmacodynamic parameters of VT7208 following a single dose in healthy volunteers. Pharmacodynamic markers are proteins that represent disease progression in MS, and will be measured by concentration of proteins within the blood.

  17. Pharmacodynamics of a multiple doses of VT7208 in healthy volunteers

    Time frame: up to 16 days

    Pharmacodynamic parameters of VT7208 following multiple doses in healthy volunteers. Pharmacodynamic markers are proteins that represent disease progression in MS, and will be measured by concentration of proteins within the blood.

  18. Pharmacodynamics of VT7208 in patients with Multiple Sclerosis

    Time frame: up to 16 weeks

    Pharmacodynamic parameters of VT7208 in participants with Multiple Sclerosis (MS). Pharmacodynamic markers are proteins that represent disease progression in MS, and will be measured by concentration of proteins within the blood.

  19. Characterize the ability of VT7208 to cross the blood brain barrier in healthy volunteers following a single dose

    Time frame: up to 8 days

    Concentration of VT7208 will be measured in cerebrospinal fluid (CSF) in healthy volunteers following a single dose.This will be measured in concentration of VT7208 within the CSF. Presence will indicate the ability of VT7208 to cross the blood/brain barrier.

  20. Characterize the ability of VT7208 to cross the blood brain barrier in healthy volunteers following multiple doses

    Time frame: up to 16 days

    Concentration of VT7208 will be measured in cerebrospinal fluid (CSF) in healthy volunteers following multiple doses.This will be measured in concentration of VT7208 within the CSF Presence will indicate the ability of VT7208 to cross the blood/brain barrier.

  21. Characterize the ability of VT7208 to cross the blood brain barrier in patients with MS

    Time frame: up to 16 weeks

    Concentration of VT7208 will be measured in cerebrospinal fluid (CSF) in patients with Multiple Sclerosis (MS). This will be measured in concentration of VT7208 within the CSF. Presence will indicate the ability of VT7208 to cross the blood/brain barrier.

Study contacts

Contact information is provided by the study sponsor or research team.

MIchele DeSciscio, MBSS

CONTACT

[email protected]

+61 (0) 422 447 902

Sponsors and collaborators

Lead sponsor

Vidya Therapeutics Inc

Industry

Collaborators

  • Vidya Therapeutics Australia Pty Ltd

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 25, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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