NCT03630094已完成1 期
A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human 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
- 发起方
- Wockhardt
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)
研究概览
简要总结
This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).
- •Medical history without any major pathology as judged by the Investigator.
- •Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.
排除标准
- •History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •Positive alcohol breath test or urine drug screen test at screening or confinement.
- •Current use or has used tobacco or nicotine containing products 6 month prior to screening.
- •Positive testing for HIV, Hepatitis B or Hepatitis C.
- •History or presence of alcohol or drug abuse within the 2 years prior to screening.
研究组 & 干预措施
FEP-ZID via intravenous
Experimental
total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
干预措施: FEP-ZID (Drug)
结局指标
主要结局
concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)
时间窗: Day 3
concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)
时间窗: Day 3
次要结局
- Number of adverse event reported(Day 3)
- number variation noted in 12-lead electrocardiogram(Day 3)
研究者
研究点 (1)
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