A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- t1/2
研究概览
简要总结
Design：Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives：
- To investigate the tolerability and safety of Chinese healthy adult subjects after a single oral administration of Finamine tablets;
- To investigate the pharmacokinetic (PK) characteristics of Finamine tablets;
- To provide dose setting basis for follow-up clinical studies. Investigational subject:Healthy-adult subjects in China
34 cases (including 4 cases of the pre- trial), of which the 150mg dose group is in the 4 cases of pre- trial (open, all accepted Finamine tablets orally, among whom, two receive it under fasting condition , and the other two receive it half an hour post a high-fat meal started). There are 6 cases in the formal trial (the subjects' ratio of investigational drug to placebo is 2:1). In all other dose groups, the subjects' ratio of investigational drug to placebo is 3:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 65 years old (including the upper and lower limits).
- •Male or female
- •Weight ≥50kg, BMI 18-28 kg/m2 (including the upper and lower limits).
- •Understand and sign the informed consent form，able to understand the process and requirements of the study, and volunteer to participate in this study.
排除标准
- •If being one of the following conditions, subjects cannot be selected
- •There is a history of disease in heart, liver, kidney, respiratory system, digestive tract, nervous system, endocrine system, immune system, blood system, etc., that the investigator has determined to be clinically significant;
- •Abnormalities are in vital signs, comprehensive physical examinations, laboratory tests, ECG examinations, etc., and they are considered clinically significant by the investigator;
- •Any drug was taken within two weeks prior to dosing in the study , and the investigators believe that this condition may affect the assessment results of this study;
- •There is an seriously allergic history of food and drug or hypersensitivity that the investigator has identified as clinically significant;
- •There are positive results of serological tests (HBsAg, anti-HCV, anti-HIV, or TP-Ab) during screening;
- •Within 1 years prior to the administration of the drug, the history of drinking or drug abuse, that the investigator believes it may affect the evaluation results of the study. Or, during screening, the alcohol breath test or the urine screening test is positive.
- •Subjects cannot quit smoking or quit drinking during the study period or subjects' carbon monoxide breath test is ≥7ppm during the screening period (when the investigator thinks it necessary, it can be further confirmed by urine cotinine test);
- •Subjects participated in any drug clinical trial within 3 months prior to study dosing;
- •Subjects donated blood ≥400mL or 2 units within 3 months prior to study dosing;
- •Subjects do not agree to avoid the use of tobacco ,alcoholic beverages or caffeinated beverages, or to avoid strenuous exercise and other factors that influence such as absorption, distribution, metabolism, and excretion of drugs during 24 hours before dosing in the trial and in the duration of the trial;
- •Pregnant or breastfeeding women, or subjects who are tested positive for serum HCG before dosing in the trial, or who are unable or unwilling to take contraception approved by researchers during the study period as directed by the investigator;
- •Subjects who, in the opinion of nvestigators, are not suitable for participating in this clinical study.
研究组 & 干预措施
pre-trial, fasting administration
2 cases were given 150mg Finamine tablets（pre-trial，fasting administration）
干预措施: Finamine tablets (Drug)
pre-trial,after high fat meal
2 cases were given 150mg Finamine tablets (pre- trial，after high fat meal)
干预措施: Finamine tablets (Drug)
formal trial-150mg
4 cases were given 150mg Finamine tablets 2 cases were given placebo
干预措施: Finamine tablets (Drug)
formal trial-150mg
4 cases were given 150mg Finamine tablets 2 cases were given placebo
干预措施: Placebo tablets (Drug)
formal trial-300mg
6 cases were given 300mg Finamine tablets 2 cases were given placebo
干预措施: Finamine tablets (Drug)
formal trial-300mg
6 cases were given 300mg Finamine tablets 2 cases were given placebo
干预措施: Placebo tablets (Drug)
formal trial-600mg
6 cases were given 600mg Finamine tablets 2 cases were given placebo
干预措施: Finamine tablets (Drug)
formal trial-600mg
6 cases were given 600mg Finamine tablets 2 cases were given placebo
干预措施: Placebo tablets (Drug)
formal trial-1200mg
6 cases were given 1200mg Finamine tablets 2 cases were given placebo
干预措施: Finamine tablets (Drug)
formal trial-1200mg
6 cases were given 1200mg Finamine tablets 2 cases were given placebo
干预措施: Placebo tablets (Drug)
结局指标
主要结局
t1/2
时间窗: From 0 to 96 hours after dosing
The PK parameters of the plasma sample.
AUC0-96h
时间窗: From 0 to 96 hours after dosing
area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing.
AE
时间窗: From 0 to 96 hours after dosing
The occurrence rate of AE.
Tolerance evaluation
时间窗: From 0 to 96 hours after dosing
maximum tolerated dose（MTD）、dose-limiting toxicity（DLT）
AUCinf
时间窗: From 0 to 96 hours after dosing
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Peak Plasma Concentration (Cmax)
时间窗: From 0 to 96 hours after dosing
The PK parameters of the plasma sample.
Tmax
时间窗: From 0 to 96 hours after dosing
The amount of time that a drug is present at the maximum concentration in serum.
次要结局
未报告次要终点