ACTRN12619001739101已完成1 期
A Phase I Clinical Study Evaluating the Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
Avance Clinical0 个研究点目标入组 40 人开始时间: 2019年12月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Healthy Volunteers:
- •1. Males and females aged 18–45 years old (inclusive) at screening;
- •2. Male volunteers no less than 50 kg, or female volunteers no less than 45 kg, with body mass index [BMI] in the range of 18.0–30.0 kg/m2 (inclusive) at screening;
- •3. Healthy volunteers, as assessed by the investigator based on past medical history, comprehensive physical examination, vital signs, and specified tests and examinations.
- •4. Female volunteers must:
- •a. Be of nonchildbearing potential ie, surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
- •b. If of childbearing potential, must have a negative pregnancy test at screening (serum test) and before study drug administration (Day -1 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method from signing the consent form until at least 90 days after the last dose of study drug.
- •5 .Be non-smokers (including tobacco and e-cigarettes) for at least 1 month prior to participation in the study.
- •6. Male volunteers, if not surgically sterilized, must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must be willing to use a condom in addition to having the female partner use a highly effective contraceptive method from signing the consent form until at least 90 days after the last dose of study drug.
- •7. Fully understand the nature, purpose, and potential benefits, inconveniences and risks of the trial. Understand the study procedure and voluntarily provide written informed consent.
- •8. 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
- •1. Any previous serious clinical conditions of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, and hematological, immunological, psychiatric and metabolic abnormalities, or any disease or physiological condition that may interfere with the results of this trial;
- •2. Clinically significant abnormalities upon physical examination, vital signs monitoring, ECG, and laboratory tests (including hematology, urinalysis, biochemistry, coagulation, thyroid function), as assessed by the investigator at screening;
- •3. Volunteers with positive hepatitis B surface antigen, positive hepatitis C antibody, positive Treponema pallidum antibody, or positive human immunodeficiency virus (HIV) antibody test results;
- •4. QTcF > 450 msec upon ECG;
- •5. Volunteers who have a history of a severe drug hypersensitivity/anaphylaxis or who are allergic to two or more drugs and foods or who are allergic to any of the ingredients in the study drug including its excipients;
- •6. Volunteers who cannot tolerate venipuncture and/or have a history of hemophobia or fear of needles;
- •7. History of long-term excessive intake (more than 8 cups per day, one cup = 250 mL) of tea, grapefruit, coffee, or caffeinated or grapefruit-based beverages;
- •8. Volunteers with a history of alcohol abuse within 3 months prior to screening, that is, more than 14 units of alcohol per week (1 unit = 285 mL of full strength beer (4.8% alcohol), 375 mL of mid strength beer (3.5% alcohol), 425 mL of low strength beer (2.7% alcohol), 30 mL of 40% hard liquor, 100 mL of wine);
- •9. Volunteers with a positive alcohol breath test;
- •10. Volunteers with a positive urine nicotine test;
- •11. Volunteers with drug abuse or dependence, or with a positive urine drugs of abuse test;
- •12. Use of any prescription medications or over-the-counter medications (including herbal medicines, diet aids, vitamins, or hormone supplements) within 14 days or 5 half-lives of the medication (whichever is longer) prior to dose administration, except occasional use of paracetamol;
- •13. Blood donation or loss of blood > 450 mL within the past 3 months;
- •14. Participation in any clinical trials within the past 3 months;
- •15. For females of childbearing potential, a positive serum pregnancy test at screening or a positive urine pregnancy test with confirmatory serum pregnancy test on Day -1;
- •16. Volunteers who plan to become pregnant within the next 6 months;
- •17. Any other factors judged by the investigator to be unsuitable for participating in this study.
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