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Multiple SclerosisPhase 1/2NCT07085507

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

A Phase 1/2 study testing VT7208 in people with Multiple Sclerosis, run by Vidya Therapeutics Inc at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
VT7208
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteAustralia
Study dates
1 Aug 2025to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Australia1 site, 1 recruiting
  • CMAX

    Adelaide, South Australia, 5000

    Katherine Mudge, +61 (0)8 7088 7900, katherine.mudge@cmax.com.au

    Recruiting

Other trials in Australia

About this study

Official 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

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.

Read the 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 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.

Being tested
VT7208, Placebo
Keywords
pharmacokinetics, healthy volunteers, pharmacodynamics, central nervous system
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VT7208Drug

    a small synthetic molecule capsule, oral

  • PlaceboDrug

    capsule, oral

Study groups in NCT07085507
Study groupRoleWhat they receive
Part 1 SAD Cohorts: Active drugExperimentalParticipants will receive a single dose of VT7208 in a dose escalation format.
Receives: Drug: VT7208
Part 1 SAD Cohorts: PlaceboPlacebo comparatorHealthy volunteers will receive a single dose of placebo
Receives: Drug: Placebo
Part 1 MAD Cohort: Active drugExperimentalHealthy volunteers will receive repeated doses of VT7208. Dose to be determined based on escalation data from SAD Cohorts
Receives: Drug: VT7208
Part 1 MAD Cohort: PlaceboPlacebo comparatorHealthy volunteers will receive repeated doses of placebo comparator.
Receives: Drug: Placebo
Part 2: Food EffectExperimentalOpen 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.
Receives: Drug: VT7208
Part 3: Patients with Multiple SclerosisExperimentalOpen label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2.
Receives: Drug: VT7208

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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.

    Measured: Up to 8 days

  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.

    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.

    Measured: Up to 16 days

  3. 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).

    Measured: Up to 16 weeks

Secondary outcomes (21)
  1. Pharmacokinetics of a single dose of VT7208-Cmax

    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

    Measured: up to 8 days

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

    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%

    Measured: up to 8 days

  3. Pharmacokinetics of a single dose of VT7208-Tmax

    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.

    Measured: up to 8 days

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

    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

    Measured: up to 8 days

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

    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%

    Measured: up to 8 days

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

    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.

    Measured: up to 8 days

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

    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

    Measured: up to 8 days

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

    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%

    Measured: up to 8 days

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

    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.

    Measured: up to 8 days

  10. Pharmacokinetics of a multiple doses of VT7208-Cmax

    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

    Measured: up to 16 days

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

    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%

    Measured: up to 16 days

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

    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.

    Measured: up to 16 days

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

    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

    Measured: up to 16 weeks

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

    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%

    Measured: up to 16 weeks

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

    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.

    Measured: up to 16 weeks

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

    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.

    Measured: up to 8 days

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

    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.

    Measured: up to 16 days

  18. Pharmacodynamics of VT7208 in patients with Multiple Sclerosis

    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.

    Measured: up to 16 weeks

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

    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.

    Measured: up to 8 days

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

    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.

    Measured: up to 16 days

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

    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.

    Measured: up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start1 Aug 2025
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07085507
Sponsor's protocol ID
VT7208-101
Status last verified
Jul 2026
First submitted
7 Jul 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VT7208 in people with Multiple Sclerosis, run by Vidya Therapeutics Inc at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MIchele DeSciscio, MBSS (+61 (0) 422 447 902, Michele.DeSciscio@cmax.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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