NCT02931214已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMI-1359 in Healthy Adult Subjects
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
- 58
- 试验地点
- 1
- 主要终点
- Treatment related adverse events
研究概览
简要总结
The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.
详细描述
This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or females, 19-60 years of age (inclusive).
- •Medically healthy with no clinically significant screening results.
- •Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
- •Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
- •Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.
排除标准
- •Subject is mentally or legally incapacitated.
- •History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
- •Normal clinical laboratory values.
- •Normal heart rate and blood pressure.
- •Blood donation or significant blood loss within 56 days prior to dosing.
- •Plasma donation within 7 days prior to dosing.
- •Participation in another clinical trial within 28 days prior to dosing.
研究组 & 干预措施
GMI-1359
Experimental
Dose escalation
干预措施: GMI-1359 (Drug)
Placebo
Experimental
Dose escalation
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment related adverse events
时间窗: 15 days
Treatment related adverse events as a measure of safety and tolerability of GMI-1359
次要结局
- Pharmacokinetics(48 hours)
- Pharmacodynamics(48 hours)
研究者
研究点 (1)
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