ACTRN12616000451404已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose EscalationStudy of the Safety, Tolerability, and Pharmacokinetics of HMPL-689 in Healthy AdultVolunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
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
- Male
入选标准
- •1. Informed consent must be obtained in writing for all subjects before enrollment into the study
- •2. Healthy male subjects aged 18 to 45 years inclusive at the time of screening
- •3. Body mass index greater than or equal to 19.0 and less than or equal to 30.0 kg/m2
- •4. Willing to comply with the contraceptive requirements of the study and must not donate sperm during the study or for 3 months afterwards. Subjects must agree to use a condom or to abstain from sexual intercourse throughout the trial and for 30 days afterwards.
排除标准
- •1. Family history of premature coronary artery disease
- •2. History of immunosuppression or opportunistic infections or receipt of a live virus vaccination within the 3 months prior to screening
- •3. Clinically significant abnormalities as determined by medical history, physical examination, or laboratory tests, especially for liver or renal function
- •4. Clinically significant findings in ECG, blood pressure, and heart rate, as determined by the Investigator
- •5. Subjects at risk for tuberculosis (TB), which is defined as:
- •a. Current clinical or laboratory evidence of active TB
- •b. History of TB
- •c. A positive QuantiFERON (Registered Trademark) test at screening or within 6 months prior to Day 1
- •6. Any medical condition requiring regular use of medication
- •7. Exposure to prescription medications within 30 days prior to Day1
- •8. Exposure to any other medication, including over-the-counter medications, herbal remedies, and vitamins 14 days prior to first dose (except for paracetamol)
- •9. Participation in another clinical trial with any investigational drug within 30 days of Day 1
- •10. Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ
- •11. Current smoker of more than 10 cigarettes or equivalent/day prior to commencing the study and unable to completely stop smoking during the study
- •12. Symptoms of a clinically significant illness in the 3 months before the study
- •13. Presence or sequelae of gastrointestinal, liver, or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- •14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, hemorrhoids, or anal diseases with regular or recent presence of blood in the feces
- •15. History of significant allergic disease (e.g. allergy to medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization/enrollment, or any food allergy
- •16. Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •17. Current evidence of drug abuse or history of drug abuse within 1 year before randomization/ enrollment
- •18. Unlikely to comply with the clinical study protocol; e.g.,uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
- •19. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
研究者
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