A Randomized, Double-Blind, Single- Multiple Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Part B:Number of patients with adverse events [Safety and Tolerability]
研究概览
简要总结
To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses of FL058 in healthy Chinese subjects.
详细描述
This study is divided into two parts: A and B.Part A discusses the safety and tolerability of IV FL058 single ascending dose (SAD) in two cohorts. Part B discusses the safety and tolerability of intravenous injection of FL058 in multiple dose (MAD) in three cohorts.
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
Part A：FL058
a single ascending dose (SAD) of intravenous (IV) FL058(2500mg~3000mg)
干预措施: FL058 (Drug)
Part A：Placebo
FL058 Placebo
干预措施: Placebo (Drug)
Part B：FL058
a multiple ascending dose (MAD) of intravenous (IV) FL058(500mg~2000mg)
干预措施: FL058 (Drug)
Part B：Placebo
FL058 Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Part B:Number of patients with adverse events [Safety and Tolerability]
时间窗: Day 1 to Day 12
Part A:Number of patients with adverse events [Safety and Tolerability]
时间窗: Day 1 to Day 7
次要结局
未报告次要终点