NCT03981887已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin 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
- 发起方
- Wockhardt
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess safety
研究概览
简要总结
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:
- Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
- Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Body mass index (BMI) ≥18 to ≤32 kg/m2, both inclusive.
- •Stable health based on a medical history without any major pathology/surgery in the 6 months before Screening and no clinically significant physical examination findings or clinical laboratory test results
- •Resting supine blood pressure of 90 to 139 mmHg (systolic) and 60 to 89 mmHg (diastolic) and a resting heart rate of 50 to 100 beats per minute at Screening and Check-in (Day -1).
- •Calculated creatinine clearance ≥80 mL/min (Cockroft-Gault method) at Screening.
- •Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the 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 study drug administration in this study.
- •History/evidence of clinically relevant pathology
- •History of clinically significant food or drug allergy
- •Positive alcohol or urine drug screen
研究组 & 干预措施
Nafithromycin 200 mg as IV infusion
Experimental
Nafithromycin 200 mg administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
干预措施: Nafithromycin (Drug)
placebo administered as IV infusion
Placebo Comparator
Placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
干预措施: Placebo (Other)
结局指标
主要结局
To assess safety
时间窗: Day 19
By measuring treatment emergent AEs
To assess multiple dose drug tolerability
时间窗: Day 19
By measuring treatment emergent AEs
次要结局
- To assess plasma PK parameters profile(Day 3)
研究者
研究点 (1)
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