A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL-523
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of a single dose of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg under fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions of a standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in Part B, in healthy male volunteers.
The secondary objective is to determine the pharmacokinetic profile of single (Part A) and multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the preliminary effect of food (Part C）
详细描述
This is a Phase I study with 3 parts:
Part A: Double blind, randomized, placebo-controlled, dose-escalating, single dose study in healthy volunteers.
Part B: Double blind, randomized, placebo-controlled, dose-escalating, multiple dose study in healthy volunteers.
Part C: Open labeled, single dose, cross-over, preliminary food effect study in healthy volunteers.
Number of subjects:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent must be obtained in writing for all subjects before enrollment into the study
- •Healthy male subjects aged 18 to 45years inclusive at the time of screening
- •Body mass index ≥19.0 and ≤ 30.0 kg/m2
- •No clinically significant abnormalities as determined by medical history and physical examination, especially with regard to the liver, bile and gastrointestinal systems
- •No clinically significant laboratory values and urinalysis, as determined by the clinical Investigator.
- •No clinically significant findings in ECG, blood pressure and heart rate, as determined by the clinical Investigator.
- •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
- •Family history of premature Coronary Heart Disease
- •Any condition requiring the regular use of any medication
- •Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to Day 1
- •Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to first dose
- •Participation in another study with any investigational drug in the 30 days preceding Day 1 of the study
- •Treatment in the previous 3 months with any drug known to have a well defined potential for toxicity to a major organ
- •Current smoker of more than 10 cigarettes or equivalent / day prior to commencing the study and unable to completely stop smoking during the study
- •Be in the exclusion period of any previous study with investigational drugs
- •Symptoms of a clinically significant illness in the 3 months before the study
- •Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- •Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, Hemorrhoids or anal diseases with regular or recent presence of blood in feces
- •History of significant allergic disease (e.g. Allergic to medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization or any food allergy
- •Blood or plasma donation of more than 500 ml during the previous 30 Days before randomization and/or more than 50 ml in the 2 weeks prior to screening
- •Known positive test for HIV
- •Known positive test for hepatitis B or C, unless caused by immunization
- •Current evidence of drug abuse or history of drug abuse within one year before randomization
- •History of alcohol abuse or active alcoholism as defined in Appendix A Definition of alcohol abuse
- •Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study
- •Adults under guardianship and people with restriction of freedom by administrative or legal decisions
- •Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
- •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
研究组 & 干预措施
HMPL-523
Single/Multiple Ascending Dose. oral administration, a single dose of 5, 20, 50, 100, 200 and 300 mg (Part A) and multiple dose of HMPL-523 at dose level based on result of Part A
干预措施: HMPL-523 (Drug)
Placebo
Placebo: oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating
时间窗: 6 months
次要结局
- To measure the plasma concentration of HMPL-523 in single and repeated doses(6 months)