A Phase I Clinical Study Evaluating the Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- AE/serious AE
研究概览
简要总结
This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Males and females aged 18-45 years old (inclusive) at screening;
- •Male volunteers no less than 50 kg, or female volunteers no less than 45 kg, with body mass index [BMI] in the range of 18.0-27.0 kg/m2 (inclusive) at screening;
- •Healthy volunteers, as assessed by the investigator based on past medical history, comprehensive physical examination, vital signs, and specified tests and examinations.
- •Fully understand the nature, purpose, and potential benefits, inconveniences and risks of the trial. Understand the study procedure and voluntarily provide written informed consent.
- •Able to communicate with the investigator and to follow all requirements of the study, and willing to be admitted into the phase I clinical facility.
排除标准
- •Those who have suffered or are currently suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality or any other disease or physiological condition that can interfere with the results;
- •Physical examination, vital sign monitoring, ECG examination, chest anteroposterior and lateral radiographs, laboratory examination (including blood routine, urine routine, blood biochemistry, coagulation function, thyroid function, blood pregnancy (only for female subjects) during screening period, and the researcher judged that the abnormality had clinical significance;
- •People with positive hepatitis B surface antigen, positive hepatitis C antibody, positive Treponema pallidum antibody, or positive AIDS virus antibody test;
- •Patients with QTcF>450 ms in ECG examination during screening;
- •Allergic constitution: such as those who are allergic to two or more drugs and foods; Or those who are allergic to any ingredient in this product and auxiliary materials; (Auxiliary materials: glacial acetic acid, sodium acetate, water for injection)
- •Those who cannot tolerate venipuncture and/or have a history of blood and needle sickness;
- •Those who have drunk too much tea, grapefruit, coffee, caffeinated or grapefruit drinks for a long time (more than 8 cups a day, 1 cup=250mL);
- •Those who have a history of alcohol abuse within 3 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit=12 ounces or 360 mL of beer, 1.5 ounces or 45 mL of spirits with 40% alcohol content, 5 ounces or 150 mL of wine), or those who have positive alcohol breath test;
- •Volunteers with a positive urine nicotine test;
- •Volunteers with drug abuse or dependence, or with a positive urine drugs of abuse test;
- •Those who have used any prescription medicine, over-the-counter medicine, Chinese herbal medicine and health care products within 14 days
- •Blood donation or loss of blood > 450 mL within the past 3 months;
- •Participation in any clinical trials within the past 3 months;
- •Volunteers who plan to become pregnant within the next 6 months;
- •Any other factors judged by the investigator to be unsuitable for participating in this study.
研究组 & 干预措施
HSK21542 0.2 μg/kg（15 min)
Healthy volunteers 0.2 μg/kg HSK21542
干预措施: HSK21542 (Drug)
HSK21542 0.5 μg/kg
Healthy volunteers 0.5 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
HSK21542 1 μg/kg （15min)
Healthy volunteers 1 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
HSK21542 1 μg/kg （2min)
Healthy volunteers 1 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
HSK21542 0.75 μg/kg
Healthy volunteers 0.75 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
HSK21542 1.5 μg/kg
Healthy volunteers 1.5 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
HSK21542 2.25 μg/kg
Healthy volunteers 2.25 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
HSK21542 3.375 μg/kg
Healthy volunteers 3.375 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
HSK21542 0.2 μg/kg（2min)
Healthy volunteers 0.2 μg/kg HSK21542 or Placebo
干预措施: HSK21542 (Drug)
结局指标
主要结局
AE/serious AE
时间窗: From screening up to 3 weeks
Adverse event/serious adverse event
Vital signs: Systolic and Diastolic Blood Pressure
时间窗: From screening up to 3 weeks
Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers.
Ramsay sedation score
时间窗: -60 minutes before administration until 24 hours after administration
Ramsay sedation score will be collected
Visual analog scale (VAS) addiction score
时间窗: from administration to 24 hours after administration
VAS addiction score will be collected
次要结局
- Peak concentration (Cmax)(-30 minutes before administration until 24 hours after administration)
- Area under the concentration-time curve（AUC）(-30 minutes before administration until 24 hours after administration)
- Tmax(-30 minutes before administration until 24 hours after administration)
- Total clearance(-30 minutes before administration until 24 hours after administration)
- Prolactin level(before administration until 24 hours after administration)
- Antidiuretic hormone level(before administration until 24 hours after administration)
- Urine volume(before administration until 24 hours after administration)