Randomized, Double-blind Placebo-controlled Phase I Study to Assess Safety, Tolerance，Pharmacokinetics of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of adverse events.
研究概览
简要总结
The purpose of this study is to assess safety, tolerance and pharmacokinetics of Multiple-dose Kukoamine B Mesilate in healthy volunteers
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
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: male or female, each sex ratio does not exceed 2/3;
- •18-45 years (including upper and lower limit), the general situation is good;
- •Body mass index (BMI) in 19-28 (including upper and lower limit of the range), bodyweight（BW）≥ 50kg (female) and 60kg (male);
- •Nearly half of the year, no child care program and agreed to take effective measures to contraception during the study period, women of childbearing age blood pregnancy test was negative;
- •Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials.Voluntarily signed the informed consents, and agreed to abide by the requirements of clinical protocols.
排除标准
- •Primary disease in important organs;
- •Mental or physical disability;
- •Familial hereditary disease;
- •Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood pressure greater than 90-140 millimeters of mercury(mmHg), beyond the scope of 50-90 millimeters of mercury(mmHg), Or pulse (HR) beyond 50bpm-100bpm;
- •Abnormal results of any clinically meaningful physical examination, vital signs, ECG or clinical laboratory;
- •History of immunodeficiency diseases, including HIV antibody positive;
- •Detection of antibody positive, hepatitis B surface antigen or antibody to hepatitis C / syphilis positive;
- •Alcohol and drug abusers;
- •Who is addicted to alcohol and tobacco (drinking 14 units of alcohol per week: 1 unit = beer 285 ml, or liquor 25 ml, or wine 1 cup. numbers of daily smoking ≥ 5) and / or not smoking and drinking in the test period;
- •Any discharge period may affect the study drug, or in the past 3 months participated in any drug clinical trials;
- •Before entering the group 4 weeks using any prescription drugs before entering the group, or use of any non prescription drugs within 2 weeks (vitamins, herbal tonics, etc.), or into the group within 2 weeks before taking effect of drug metabolizing enzymes in food, such as grapefruit or grapefruit drink. Can the use of acetaminophen, but must record report in case report form（CRF）;
- •The last 3 months had a history of blood donation or significant blood loss (more than 400ml);
- •There are drugs, the clinical significance of the history of food allergy and atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug to test drugs or similar drug allergy test;
- •Lactating women, pregnant women or unable to take effective contraceptive measures;
- •Researchers believe that participants not suitable to take the test for other factors .
研究组 & 干预措施
Kukoamine B Mesilate 0.06mg/kg
Dose Escalation: Kukoamine B Mesilate 0.06mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
干预措施: Kukoamine B Mesilate (Drug)
Kukoamine B Mesilate 0.12mg/kg
Dose Escalation: Kukoamine B Mesilate 0.12mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
干预措施: Kukoamine B Mesilate (Drug)
Kukoamine B Mesilate 0.24mg/kg
Dose Escalation: Kukoamine B Mesilate 0.24mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
干预措施: Kukoamine B Mesilate (Drug)
Placebo 0.06mg/kg
Dose Escalation: placebo 0.06mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
干预措施: placebo multiple doses (Drug)
Placebo 0.12mg/kg
Dose Escalation: placebo 0.12mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
干预措施: placebo multiple doses (Drug)
Placebo 0.24mg/kg
Dose Escalation: placebo 0.24mg/kg multiple-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
干预措施: placebo multiple doses (Drug)
结局指标
主要结局
Incidence of adverse events.
时间窗: 14 days
adverse event, physical examination, monitoring of vital signs, Laboratory examination, electrocardiogram(ECG).
次要结局
- Pharmacokinetic parameters(Maximum Plasma Concentration [Cmax])(the first day,the sixth day(before the three injections from bottom),the seventh day)