NCT04314206已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Healthy adults 18-55 years
- •Males or non-pregnant, non-lactating females
- •Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- •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 drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- •Use of antacid medications
- •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-5024
Experimental
Capsule formulation
干预措施: VNRX-5024 (Drug)
Placebo
Placebo Comparator
Placebo for VNRX-5024
干预措施: Placebo for VNRX-5024 (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Day 19
次要结局
- Part 1: Cmax(Days 1-2)
- Part 2: Cmax(Days 3-12)
- Part 1: tmax(Days 1-2)
- Part 2: tmax(Days 3-12)
- Part 1: CLr(Days 1-2)
- Part 2: CLr(Days 3-12)
- Part 1: AUC0-tau(Days 1-2)
- Part 2: AUC0-tau(Days 3-12)
研究者
研究点 (1)
Loading locations...
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