NCT04951505已完成1 期
A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy 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
- 30
- 试验地点
- 1
- 主要终点
- ELF Cmax
研究概览
简要总结
This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 kg/m2 and ≤32.0 kg/m2, weight >50.0 kg.
- •Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study
排除标准
- •History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
- •History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- •Recent history of known or suspected Clostridioides difficile infection
- •Abnormal ECG or history of clinically significant abnormal rhythm disorder
- •Abnormal lab tests
研究组 & 干预措施
cefepime-taniborbactam
Experimental
干预措施: cefepime-taniborbactam (Drug)
结局指标
主要结局
ELF Cmax
时间窗: 0-8 hours after 6th dose
Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF)
次要结局
- Number of subjects with adverse events(Day 1 - Day 8)
研究者
研究点 (1)
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