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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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 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.
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. — 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.
Incidence, 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 To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with Multiple Sclerosis (MS).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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