NCT02703051已完成1 期
A Phase 1, Open-Label Study to Evaluate the Pharmacodynamics, Safety and Tolerability of GMI-1271 With and Without Filgrastim 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
- 54
- 试验地点
- 1
- 主要终点
- Measurement of subsets of WBC
研究概览
简要总结
Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
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 and/or females, 19 to 60 years of age, inclusive.
- •Medically healthy with no clinically significant screening results as deemed by the PI.
排除标准
- •History of presence of clinically significant medical condition or disease in the opinion of the PI.
- •Alcoholism or drug abuse.
- •Liver disease.
- •Female subjects who are pregnant or lactating.
- •Known history or evidence of active hepatitis A, B, or C or HIV.
- •Clinically significant cardiovascular disease.
- •Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.
研究组 & 干预措施
Filgrastim
Active Comparator
Filgrastim
干预措施: Placebo Infusion (Drug)
GMI-1271
Experimental
GMI-1271
干预措施: Placebo Injection (Drug)
Filgrastim
Active Comparator
Filgrastim
干预措施: Filgrastim (Drug)
GMI-1271
Experimental
GMI-1271
干预措施: GMI-1271 (Drug)
GMI-1271 with Filgrastim
Experimental
GMI-1271 with Filgrastim
干预措施: Filgrastim (Drug)
GMI-1271 with Filgrastim
Experimental
GMI-1271 with Filgrastim
干预措施: GMI-1271 (Drug)
结局指标
主要结局
Measurement of subsets of WBC
时间窗: 10 days
次要结局
- Number of adverse events as a measure of safety and tolerability(19 days)
研究者
研究点 (1)
Loading locations...
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