A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a Kappa Receptor Agonist HSK21542 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers.
The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.
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 male and female subjects, age 18-45 years;
- •BMI between 18.0-27.0 kg/m2
- •Determined by investigator to be in general good health according to medical history, comprehensive physical examination;
- •Understanding of the nature, significance, potential benefits and risks of the trial, understanding of the procedures and be able to provide written informed consent voluntarily ;
- •Good communication with investigators, compliance with the study requirements and willingness to stay in phase I clinical trial ward as required.
排除标准
- •Anyone who has suffered or is currently suffering from any serious diseases, that may interfere with the results of the trial;
- •Determined by investigator to be abnormal with clinical significance in Physical examination, vital signs monitoring, electrocardiogram, chest radiograph, laboratory examination;
- •HBsAg positive, HCV antibody positive, Treponema pallidum antibody positive, or HIV antibody positive;
- •QTcF > 450ms;
- •Allergic constitution;
- •Intolerance of venipuncture and/or history of haemorrhage or needle fainting;
- •Drug or alcohol abuse;
- •Have used any prescription, over-the-counter, Chinese herbal medicine or health products within 14 days;
- •Blood donation or massive bleeding within 3 months (greater than 450 mL);
- •Participants in any drug clinical trial within 3 months.
- •Birth planning in the next six months.
研究组 & 干预措施
HSK21542 single ascending doses
干预措施: HSK21542 (Drug)
Placebo single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Between screening and 7-9 days after dosing
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events
Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
时间窗: Between screening and 7-9 days after dosing
To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
次要结局
- t1/2(From the start of administration to 24 hours after administration)
- Tmax(From the start of administration to 24 hours after administration)
- AUC0-t(From the start of administration to 24 hours after administration)
- CL(From the start of administration to 24 hours after administration)
- Vd(From the start of administration to 24 hours after administration)
- Cmax(From the start of administration to 24 hours after administration)
- AUC0-inf(From the start of administration to 24 hours after administration)