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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose.
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Part 3: Patients with Multiple Sclerosis
Open label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2.
Intervention: VT7208 (Drug)
Part 1 SAD Cohorts: Active drug
Participants will receive a single dose of VT7208 in a dose escalation format.
Intervention: VT7208 (Drug)
Part 1 SAD Cohorts: Placebo
Healthy volunteers will receive a single dose of placebo
Intervention: Placebo (Drug)
Part 1 MAD Cohort: Active drug
Healthy volunteers will receive repeated doses of VT7208. Dose to be determined based on escalation data from SAD Cohorts
Intervention: VT7208 (Drug)
Part 1 MAD Cohort: Placebo
Healthy volunteers will receive repeated doses of placebo comparator.
Intervention: Placebo (Drug)
Part 2: Food Effect
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.
Intervention: VT7208 (Drug)
Outcomes
Primary Outcomes
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.
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.
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
- 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)
- Pharmacokinetics of a single dose of VT7208 fed state: Tmax(up to 8 days)
- Pharmacokinetics of a single dose of VT7208 fasted state: Cmax(up to 8 days)
- Pharmacokinetics of a single dose of VT7208 fasted state: T 1/2(up to 8 days)
- Pharmacokinetics of a single dose of VT7208 fasted state: Tmax(up to 8 days)
- Pharmacokinetics of a multiple doses of VT7208-Cmax(up to 16 days)
- Pharmacokinetics of a multiple doses of VT7208-T 1/2(up to 16 days)
- Pharmacokinetics of a multiple doses of VT7208-T max(up to 16 days)
- Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-Cmax(up to 16 weeks)
- Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-T 1/2(up to 16 weeks)
- Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-Tmax(up to 16 weeks)
- Pharmacodynamics of a single dose of VT7208 in healthy volunteers(up to 8 days)
- Pharmacodynamics of a multiple doses of VT7208 in healthy volunteers(up to 16 days)
- Pharmacodynamics of VT7208 in patients with Multiple Sclerosis(up to 16 weeks)
- Characterize the ability of VT7208 to cross the blood brain barrier in healthy volunteers following a single dose(up to 8 days)
- Characterize the ability of VT7208 to cross the blood brain barrier in healthy volunteers following multiple doses(up to 16 days)
- Characterize the ability of VT7208 to cross the blood brain barrier in patients with MS(up to 16 weeks)