NCT03680378已完成1 期
A Phase I Open-Label, Single-Centre Study to Assess the Concentration of AAI101 and Cefepime in Epithelial Lining Fluid and Plasma in Healthy Volunteers
Allecra1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年7月1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
- 19
- 试验地点
- 1
- 主要终点
- Maximum concentration of cefepime and AAI101 in the lung
研究概览
简要总结
The primary objective of this study is to measure and compare the concentration of AAI101 and cefepime in bronchial epithelial lining fluid (ELF) and plasma following administration of cefepime/AAI101 combination in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cefepime 2 gram + AAI101 1 gram
Experimental
cefepime 2 grams in combination with AAI101 1 gram intravenous infusion
干预措施: Cefepime 2 gram (Drug)
结局指标
主要结局
Maximum concentration of cefepime and AAI101 in the lung
时间窗: Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose
Maximum concentration of cefepime and AAI101 in Bronchoalveolar lavage (BAL) samples
次要结局
- Maximum concentration of cefepime and AAI101 in plasma(Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose)
研究者
研究点 (1)
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