Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Part 1: Number of subjects with adverse events
研究概览
简要总结
This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.
详细描述
In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adults 18-55 years
- •Males or non-pregnant, non-lactating females
- •Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight >50 kg (110 lbs)
- •Normal blood pressure
- •Normal lab tests
排除标准
- •Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- •History of severe allergic or anaphylactic reaction
- •Abnormal ECG or history of clinically significant abnormal rhythm disorder
- •Positive alcohol, drug, or tobacco use/test
研究组 & 干预措施
VNRX-9945
Oral dosing
干预措施: VNRX-9945 (Drug)
Placebo
Oral dosing
干预措施: Placebo for VNRX-9945 (Drug)
结局指标
主要结局
Part 1: Number of subjects with adverse events
时间窗: Up to 8 days after last administration of study drug
Part 2: Number of subjects with adverse events
时间窗: Up to 8 days after last administration of study drug
次要结局
- Part 1: AUCinf(Days 1-6 (Days 1-12 for fasted/fed cohort))
- Part 1: AUC0-tau(Days 1-6 (Days 1-12 for fasted/fed cohort))
- Part 1: t1/2(Days 1-6 (Days 1-12 for fasted/fed cohort))
- Part 1: tmax(Days 1-6 (Days 1-12 for fasted/fed cohort))
- Part 2: Cmax(Day 1 and Following Last Dose on Day 14)
- Part 1: Cmax(Days 1-6 (Days 1-12 for fasted/fed cohort))
- Part 2: AUC0-tau(Day 1 and Following Last Dose on Day 14)
- Part 2: tmax(Day 1 and Following Last Dose on Day 14)
- Part 2: t1/2(Following Last Dose on Day 14)