A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Intravenous Administration in Healthy Subjects 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
- 74
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy volunteer, age 18-56 years
- •BMI between 18-34 kg/m2,and body weight not less than 50.0kg.
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 single dose
HNC042,freeze-dried powder,single ascending doses Single dose,
干预措施: HNC042 single dose (Drug)
Placebo single dose
Placebo single ascending doses , Intravenous route Single dose
干预措施: Placebo single dose (Drug)
HNC042 multiple ascending doses
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route
干预措施: HNC042 multiple ascending doses (Drug)
Placebo, multiple ascending doses
Placebo, multiple ascending doses, Intravenous route,
干预措施: Placebo multiple ascending doses (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of adverse events
Number of subjects with abnormal laboratory
时间窗: Between screening and 7days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after single and multiple intravenous dose in healthy subjects in terms of abnormal laboratory
Number of subjects with abnormal electrocardiogram
时间窗: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal electrocardiogram
Number of subjects with abnormal vital signs
时间窗: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal vital signs
Number of subjects with abnormal physical examination
时间窗: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal physical examination
次要结局
- The amount of HNC042 in urine(Between Day 1 predose and 24 hours after the (last) dose)
- The amount of HNC042 in plasma(Between Day 1 predose and 24 hours after the (last) dose)