NCT03055403已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
Yuji KUMAGAI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.
详细描述
Not Provided
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
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Japanese Healthy Male subjects
- •Age 20 to less than 40 years of age
- •Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2
- •Written informed consent must be obtained on a voluntary basis before any assessment is performed.
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
- •Past medical history of cancer, cerebral infarction or cardiac infarction
- •Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
- •QTcF > 450ms at the screening examination
- •NT-proBNP > 125 pg/mL at the screening examination
- •Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
研究组 & 干预措施
M201-A Injection
Experimental
Active Substance: M201-A Route of administration: continuous intravenous injection
干预措施: M201-A Injection (Drug)
Placebo
Placebo Comparator
Saline Placebo for M201-A Route of administration: continuous intravenous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: Throughout the study duration (up to day8)
adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.
次要结局
- Pharmacokinetics-AUC0-∞(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
- Pharmacokinetics-CL(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
- Pharmacokinetics-E0-24(up to 24 hours)
- Pharmacokinetics-Cmax(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
- Pharmacokinetics-Tmax(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
- Pharmacokinetics-t1/2(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
- Pharmacokinetics-AUC0-24(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
- Pharmacokinetics-AUC0-t(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
- Pharmacokinetics-Ae(up to 24 hours)
- Pharmacokinetics-Vd(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
研究者
Yuji KUMAGAI
Professor
Kitasato University
研究点 (1)
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