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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: VT7208 (Drug)
Part 1 SAD Cohorts: Active drug
Participants will receive a single dose of VT7208 in a dose escalation format.
干预措施: VT7208 (Drug)
Part 1 SAD Cohorts: Placebo
Healthy volunteers will receive a single dose of placebo
干预措施: 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
干预措施: VT7208 (Drug)
Part 1 MAD Cohort: Placebo
Healthy volunteers will receive repeated doses of placebo comparator.
干预措施: 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.
干预措施: VT7208 (Drug)
结局指标
主要结局
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose.
时间窗: 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.
时间窗: 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
时间窗: 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).
次要结局
- 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)