A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Multiple Ascending Doses Study Following Intravenous Administration in Healthy Chinese Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse reactions at injection site
研究概览
简要总结
The purpose of this study is to evaluate the safety , tolerability and pharmacokinetics after multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent
- •Healthy adult male or female volunteers, age 18-65 years，
- •BMI between 19-26 kg/m2,and male body weight not less than 50.0kg,female body weight not less than 45.0kg .
- •volunteers with normal renal function
排除标准
- •Any condition that might interfere with the procedures or tests in this study
- •Drug or alcohol abuse
研究组 & 干预措施
HNC042
HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route
干预措施: HNC042 for Injection (Drug)
Placebo
Placebo, multiple ascending doses, Intravenous route
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Number of subjects with adverse reactions at injection site
时间窗: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse reactions at injection site
Number of subjects with adverse events
时间窗: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse events
Number of subjects with abnormal laboratory
时间窗: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory
Number of subjects with abnormal electrocardiogram
时间窗: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal electrocardiogram
Number of subjects with abnormal physical examination
时间窗: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal physical examination
Number of subjects with abnormal vital signs
时间窗: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs
Number of subjects with clinical symptoms
时间窗: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of clinical symptoms
次要结局
- Pharmacokinetics of HNC042 in plasma: Tmax(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:MRT(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma: AUC0-∞(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:CL(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma: AUC0-last(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma: Cmax(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:t1/2(Between Day 1 to 7 days)
- Pharmacokinetics of HNC042 in plasma:Vd(Between Day 1 to 7 days)