NCT02707107已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 5222 (Zidebactam and Cefepime) 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
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
研究概览
简要总结
Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height(m2).
- •Resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
- •Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
- •All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
排除标准
- •Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before investigational product administration in this study.
- •History/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the Principal Investigator would confound the subject's participation and follow-up in the study.
- •History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
- •History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
- •Prior exposure to zidebactam.
研究组 & 干预措施
3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6
Active Comparator
administered as IV infusions every q8h, over a period of 60 minutes.
干预措施: Intravenous infusions of WCK 5222 (Drug)
Placebo
Placebo Comparator
administered as IV infusions every q8h, over a period of 60 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
时间窗: 14 days
次要结局
- Maximum plasma concentration(7 days)
- Time to Cmax(7 days)
研究者
研究点 (1)
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