A Randomized, Blind, Placebo-controlled,Single Andmultiple Ascending Dose Study to Assess the Safety,Tolerability, and Pharmacokinetic of KPCXM18 for Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 102
- 主要终点
- Number of subjects with abnormal laboratory
研究概览
简要总结
to assess the safety,Tolerability, and pharmacokinetic of KPCXM18 for injection in healthy subjects
详细描述
To explore the safety, tolerance and pharmacokinetic of KPCXM18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase II clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ；
- •General physical examination and physical and chemical examination are qualified.
- •Volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent；
排除标准
- •Any condition that might interfere with the procedures or tests in this study;
- •Drinking（more than 14 units of alcohol per week） in 6 months ;
- •Smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ;
- •Have special requirements on diet, or cannot follow a unified diet ;
- •Used a clinical trial drug within 3 months prior to administration ;
- •Positive blood pregnancy test of female subjects ;
- •Subjects may not be able to complete the study for other reasons or the investigator considers that they should not be included .
研究组 & 干预措施
KPCXM18 for injection
KPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route
干预措施: KPCXM18 (Drug)
KPCXM18 for injection
KPCXM18 ，freeze-dried powder,single and multiple ascending doses, Intravenous route
干预措施: Placebo (Drug)
Placebo
Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route
干预措施: KPCXM18 (Drug)
Placebo
Placebo, freeze-dried powder,single and multiple ascending doses, Intravenous route
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with abnormal laboratory
时间窗: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory
Number of subjects with abnormal vital signs
时间窗: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs
Number of subjects with abnormal physical examination
时间窗: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal physical examination
Number of subjects with abnormal electrocardiogram
时间窗: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal electrocardiogram
Number of subjects with adverse events
时间窗: through study completion, an average of 2 week
To evaluate the safety KPCXM 18 for Injection with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal adverse events
次要结局
- Pharmacokinetics of KPCXM18 in plasma: AUC0-∞,ss(Time Frame: Between Day 1 to 14 days)
- Pharmacokinetics of KPCXM18 in plasma: Cmax(Time Frame: Between Day 1 to 7 days)
- Pharmacokinetics of KPCXM18 in plasma: AUC0-∞(Time Frame: Between Day 1 to 7 days)
- Pharmacokinetics of KPCXM18 in plasma: Tmax,ss(Time Frame: Between Day 1 to 14 days)
- Pharmacokinetics of KPCXM18 in plasma:t1/2(Time Frame: Between Day 1 to 7 days)
- Pharmacokinetics of KPCXM18 in plasma: Cmax,ss(Time Frame: Between Day 1 to 14 days)
- Pharmacokinetics of KPCXM18 in plasma: Tmax(Time Frame: Between Day 1 to 7 days)