Phase-I, Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771 in Adult Healthy Human Volunteers
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
- To evaluate the safety & tolerability of multiple doses of WCK 771
研究概览
简要总结
The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg/height in m2
- •Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings
排除标准
- •Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs
- •Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
- •Use of any prescription drug within 14 days prior to start of the study (check-in) and nonprescription drug within 7 days prior to start of study (check-in)
研究组 & 干预措施
WCK 771
WCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion
干预措施: WCK 771 IV Infusion (Drug)
Placebo infusion
Matching Placebo administered as IV infusion
干预措施: Placebo IV Infusion (Other)
结局指标
主要结局
To evaluate the safety & tolerability of multiple doses of WCK 771
时间窗: Day 12
By monitoring the adverse events reported
To evaluate the pharmacokinetics of multiple doses of WCK 771
时间窗: Day 5
Measuring Cmax Maximum observed plasma concentration.
次要结局
未报告次要终点