A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject between 18 and 55 years of age, both inclusive,
- •creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).
排除标准
- •Clinically relevant pathology or any other systemic disorder/major surgeries that in the opinion of the investigator would confound the subject's participation and follow-up in the clinical study.
- •Drug or food allergy.
研究组 & 干预措施
Nafithromycin
Subjects in Cohorts 1 through 5 receive active treatments. Subjects in Cohort 6 will receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period.
Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin on Day 1
干预措施: Nafithromycin (Drug)
Placebo
Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments.
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: 72 hours from dosing
Time to Cmax (Tmax)
时间窗: 72 hours from dosing
Area under the plasma concentration-time curve
时间窗: 72 hours from dosing
次要结局
- clinical laboratory- Number of subjects with deranged heamatology parameters test results(14 days)
- Number of subjects with any abonormal physical examination findings(14 days)
- 12-lead safety ECG results(14 days)
- Number of subjects reported with any local tolerability at the injection site assessments(14 days)
- Total number of reported AEs(14 days)