A Dose-increasing, Randomized, Double-blind, Placebo-controlled, Single-dose/multiple-dose Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection in Healthy Chinese Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Adverse event
研究概览
简要总结
This is a Phase I clinical to evaluate the safety and tolerability of single and multiple intravenous infusions of AAPB at different doses over 7 consecutive days.
详细描述
This is a dose-increasing, randomized, double-blind, placebo-controlled, single-dose/multiple-dose phase I clinical trial evaluating the safety, tolerability and pharmacokinetics of AAPB for injection in healthy Chinese subjects.
The objective of this study was to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple intravenous infusion of AAPB at different doses for 7 consecutive days, and to explore the metabolites and mass balance of AAPB for injection in vivo. It provides a research basis for exploring the efficacy and safety of AAPB for injection in the treatment of acute ischemic death.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy subjects, aged between 18 and 45 (both ends included), both male and female;
- •When screening patients, male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg/m^2 (including the upper and lower limits), BMI= weight (kg)/height (m) ^2;
- •Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the program;
- •Women or men of reproductive age who agree to use investigatorial-approved contraceptive methods (such as Iuds, condoms, spermicide gel plus condoms, diaphragms, etc.) throughout the trial period;
- •Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial.
排除标准
- •The investigator determines that the subject has a history of present disease and past disease or dysfunction affecting the clinical trial, including but not limited to diseases of the nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, metabolic disease, rheumatic disease, blood system, etc.;
- •Suffers from mental illness or has a history of mental illness;
- •Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
- •History of cardiovascular disease (such as heart dysfunction, coronary artery disease, cardiomyopathy, valvular heart disease, family history of congenital long QT syndrome, family history of sudden death, etc.) or ECG results showing QTcF > 450ms, or clinically significant conduction block or T wave changes;
- •Abnormal liver function (ALT, AST higher than the upper limit of normal reference value);
- •Any drugs that inhibit or induce liver drug metabolism enzymes (such as: inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.) were used within 30 days before drug administration; Inhibitors 5-hydroxyserotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc. Or any prescription, over-the-counter, and herbal medicines other than those described above have been taken in the 14 days prior to drug administration;
- •Participated in any clinical trials within 3 months before enrollment;
- •Those who have special requirements for food and cannot comply with a unified diet;
- •People who consumed any caffeine-rich food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the study drug administration, or who do not agree to prohibit the use of any caffeine-rich food or drink during the study period;
- •Known allergic history of test drug ingredients or similar drugs, allergic disease history or allergic constitution;
- •Smokers who smoked more than 10 cigarettes or equivalent cigarettes per day in the 1 year prior to screening, or those who could not comply with the prohibition of smoking during the test period;
- •Alcohol-addicted persons with an average weekly alcohol intake of more than 14 units (1 unit =285ml beer or 25ml spirits or 150ml wine) or positive for alcohol breath test in the year before screening;
- •Persons with a history of drug or drug abuse within the year prior to screening, or who test positive for drug abuse (screening items include: morphine, THC, methamphetamine, dimethylene dioxyamphetamine, ketamine and cocaine);
- •Complete physical examination, vital signs, laboratory examination, ECG examination determined by the investigator to be abnormal and clinically significant;
- •Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-AB), Treponema pallidum antibody (TP-Ab) any of the positive results;
- •Women who are pregnant or nursing, or who test positive for serum HCG before trial administration, or who are unable or unwilling to use investigator-approved contraception during the study period and for 3 months after the end of the study as directed by the investigator;
- •Study blood donation or blood loss ≥200ml within 3 months before drug administration, or have a history of blood product use;
- •Patients with a history of surgery within 3 months prior to study administration, or who have not recovered from surgery, or who have an anticipated surgical plan during the trial period;
- •Persons directly related to the clinical trial;
- •Patients who cannot tolerate venipunction and have a history of fainting needles and fainting blood;
- •Other subjects deemed unsuitable for this study by the investigator.
研究组 & 干预措施
Single administration of-AAPB-10mg group
10mg of AAPB for injection was administered as a single intravenous drip
干预措施: Single dose, AAPB by injection, intravenous drip. (Drug)
Single dose - placebo -10mg group
10mg of placebo was administered as a single intravenous infusion
干预措施: Single dose, placebo, intravenous drip. (Other)
Single administration of -AAPB-25mg group
25mg AAPB for injection.The drug was administered as a single intravenous drip
干预措施: Single dose, AAPB by injection, intravenous drip. (Drug)
Single dose - placebo -25mg group
25mg of placebo was administered as a single intravenous infusion
干预措施: Single dose, placebo, intravenous drip. (Other)
Single administration of -AAPB-50mg group
50mg AAPB for injection.The drug was administered as a single intravenous drip
干预措施: Single dose, AAPB by injection, intravenous drip. (Drug)
Single dose - placebo -50mg group
50mg of placebo was administered as a single intravenous infusion
干预措施: Single dose, placebo, intravenous drip. (Other)
Single administration of -AAPB-75mg group
75mg AAPB for injection.The drug was administered as a single intravenous drip
干预措施: Single dose, AAPB by injection, intravenous drip. (Drug)
Single dose - placebo -75mg group
75mg of placebo was administered as a single intravenous infusion
干预措施: Single dose, placebo, intravenous drip. (Other)
Single administration of-AAPB-100mg group
100mg AAPB for injection.The drug was administered as a single intravenous drip
干预措施: Single dose, AAPB by injection, intravenous drip. (Drug)
Single dose - placebo -100mg group
100mg of placebo was administered as a single intravenous infusion
干预措施: Single dose, placebo, intravenous drip. (Other)
Multiple administration-AAPB-A group for injection
AAPB-A group dose for injection An intravenous drip. Once a day for 7 days
干预措施: Multiple dosing, AAPB for injection, intravenous drip (Drug)
Multiple dosing -Placebo-A group
Placebo, Group A dose, Intravenous infusion, Once a day for 7 days
干预措施: Multiple dosing, placebo, IV drip (Other)
Multiple administration-AAPB-B group for injection
AAPB-B group dose for injection An intravenous drip. Once a day for 7 days
干预措施: Multiple dosing, AAPB for injection, intravenous drip (Drug)
Multiple dosing -Placebo-B group
Placebo, Group B dose, Intravenous infusion, Once a day for 7 days
干预措施: Multiple dosing, placebo, IV drip (Other)
结局指标
主要结局
Adverse event
时间窗: Simple ascending dose, follow-up visit from day 1 to day 3. Multiple Ascending Dose, follow-up visit from day 1 to day 8.
Incidence of Adverse Events
次要结局
- Serum Human chorionic gonadotropin in female subjects of reproductive age(Screening period (day-14 ~ day-1)，Baseline Period (day0)，Final follow-up period(day3/day8))
- Maximum plasma concentration (Cmax)(Day1~day2)
- Time to maximum plasma concentration (Tmax)(Day1-day2)
- Elimination half-life (t1/2)(Day1-day2)
- clearance, CL(Day1-day2)
- Apparent distribution volume (Vz)(Day1-day2)
- Steady statetime time to maximum plasma concentration （Tmax_ss）(Day1-day2， Day4-day8)
- steady state minimal concentration（Cmin,ss）(Day1-day2， Day4-day8)
- steady state maximum concentration（Cmax,ss）(Day1-day2， Day4-day8)
- Fluctuation Factor （DF）(Day1-day2， Day4-day8)
- steady state clearance（CLss）(Day1-day2， Day4-day8)
- 12-lead electrocardiogram interpretation(Screening period (day-14 ~ day-1)，Baseline Period (day0)，Administration observation period (day1~3 /day1~8)， Final follow-up period(day3/day8))
- Blood pressure(Screening period (day-14 ~ day-1)，Baseline Period (day0)，Administration observation period (day1~3 /day1~8)， Final follow-up period(day3/day8))
- Respiration(Screening period (day-14 ~ day-1)，Baseline Period (day0)，Administration observation period (day1~3 /day1~8)， Final follow-up period(day3/day8))
- Heart rate(Screening period (day-14 ~ day-1)，Baseline Period (day0)，Administration observation period (day1~3 /day1~8)， Final follow-up period(day3/day8))
- Temperature(Screening period (day-14 ~ day-1)，Baseline Period (day0)，Administration observation period (day1~3 /day1~8)， Final follow-up period(day3/day8))