A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC664
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of subjects with vital sign measurements
研究概览
简要总结
The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect 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 18-65 years
- •BMI between 18-32 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
HNC664 capsules
HNC664 capsules,single ascending doses Single dose
干预措施: HNC664 capsules Single dose (Drug)
HNC664 placebos
HNC664 placebos,single ascending doses Single dose
干预措施: HNC664 placebos Single dose (Drug)
HNC664 capsules FED
HNC664 capsules,food effect,Single dose
干预措施: HNC664 capsules FED (Drug)
结局指标
主要结局
Number of subjects with vital sign measurements
时间窗: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs
Number of subjects with clinical laboratory test results
时间窗: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results
Number of subjects with 12-lead ECGs
时间窗: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal 12-lead ECGs
Number of subjects with physical examinations
时间窗: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal physical examinations
Number of subjects with adverse events and concomitant medications
时间窗: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.
次要结局
未报告次要终点