Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208
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
What it found
No result yet.
What was tested
Treatment tested
- VT7208
Placebo
- Placebo
What it measured
Main measures
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose.
Up to 8 days
SafetyIncidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers who receive multiple daily doses.
Up to 16 days
SafetyIncidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of daily VT7208 in patients with MS
Up to 16 weeks
Safety
Other measures (21)
Pharmacokinetics of a single dose of VT7208-Cmax
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208-T 1/2
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208-Tmax
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208 fed state: Cmax
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208 fed state: T 1/2
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208 fed state: Tmax
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208 fasted state: Cmax
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208 fasted state: T 1/2
up to 8 days
How the body handles the medicinePharmacokinetics of a single dose of VT7208 fasted state: Tmax
up to 8 days
How the body handles the medicinePharmacokinetics of a multiple doses of VT7208-Cmax
up to 16 days
How the body handles the medicine
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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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History
Started
Aug 2025
Main results due
Oct 2026
Finished
Dec 2027