A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous FL058 and Meropenem Alone and in Combination in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events [Safety and Tolerability]
研究概览
简要总结
Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy adults aged between 18 and 45 years (inclusive).
- •Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
- •Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
- •Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.
排除标准
- •Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
- •Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
- •History of clinically significant food or drug allergy.
- •A QT interval corrected using Fridericia's formula >450 msec.
- •eGFR<90mL/min/1.73m2.
研究组 & 干预措施
FL058 2000mg and Meropenem 2000mg
FL058 2000mg and Meropenem 2000mg (8 subjects);
FL058 Placebo and Meropenem 2000mg(2 subjects)
干预措施: FL058 Placebo and Meropenem 2000mg（ IV 180min） (Drug)
FL058 500mg and Meropenem 1000mg
FL058 500mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: FL058 500mg and Meropenem 1000mg（ IV 120min） (Drug)
FL058 500mg and Meropenem 1000mg
FL058 500mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: FL058 Placebo and Meropenem 1000mg（ IV 120min） (Drug)
FL058 1000mg and Meropenem 1000mg
D1
FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects);
D4
Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects);
D7~ D15
FL058 1000mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: FL058 1000mg（ IV 120min） (Drug)
FL058 1000mg and Meropenem 1000mg
D1
FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects);
D4
Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects);
D7~ D15
FL058 1000mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: FL058 Placebo （ IV 120min） (Drug)
FL058 1000mg and Meropenem 1000mg
D1
FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects);
D4
Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects);
D7~ D15
FL058 1000mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: Meropenem 1000 mg （ IV 120min） (Drug)
FL058 1000mg and Meropenem 1000mg
D1
FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects);
D4
Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects);
D7~ D15
FL058 1000mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: Meropenem Placebo （ IV 120min） (Drug)
FL058 1000mg and Meropenem 1000mg
D1
FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects);
D4
Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects);
D7~ D15
FL058 1000mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: FL058 1000mg and Meropenem 1000mg （ IV 120min） (Drug)
FL058 1000mg and Meropenem 1000mg
D1
FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects);
D4
Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects);
D7~ D15
FL058 1000mg and Meropenem 1000mg (8 subjects);
FL058 Placebo and Meropenem 1000mg(2 subjects)
干预措施: FL058 Placebo and Meropenem 1000mg （ IV 120min） (Drug)
FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 1000mg and Meropenem 2000mg (8 subjects);
FL058 Placebo and Meropenem 2000mg(2 subjects)
干预措施: FL058 1000mg and Meropenem 2000mg （ IV 120min） (Drug)
FL058 1000mg and Meropenem 2000mg (IV 120min)
FL058 1000mg and Meropenem 2000mg (8 subjects);
FL058 Placebo and Meropenem 2000mg(2 subjects)
干预措施: FL058 Placebo and Meropenem 2000m（ IV 120min） (Drug)
FL058 1000mg and Meropenem 2000mg (IV 180min)
FL058 1000mg and Meropenem 2000mg (8 subjects);
FL058 Placebo and Meropenem 2000mg(2 subjects)
干预措施: FL058 1000mg and Meropenem 2000mg （ IV 180min） (Drug)
FL058 1000mg and Meropenem 2000mg (IV 180min)
FL058 1000mg and Meropenem 2000mg (8 subjects);
FL058 Placebo and Meropenem 2000mg(2 subjects)
干预措施: FL058 Placebo and Meropenem 2000m（ IV 180min） (Drug)
FL058 2000mg and Meropenem 2000mg
FL058 2000mg and Meropenem 2000mg (8 subjects);
FL058 Placebo and Meropenem 2000mg(2 subjects)
干预措施: FL058 2000mg and Meropenem 2000mg（ IV 180min） (Drug)
结局指标
主要结局
Number of patients with adverse events [Safety and Tolerability]
时间窗: Day 1 to Day 24
次要结局
未报告次要终点