Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic characteristics of single administration of AD16 tablets in healthy adults under fasting conditions, and the secondary objective was to preliminarily evaluate the material balance of single administration of AD16 tablets in fasting conditions.
The study is divided into two parts: preliminary test and formal test. The formal trial was a single-center, randomized, placebo-controlled, double-blind, dose-increasing study, with 5 dose groups (5mg, 10mg, 20mg, 30mg and 40mg, respectively).
Ten subjects (male and female) were enrolled in each dose group, of which 8 received the experimental drug and 2 received placebo.
Urine and fecal samples were collected in the 20mg dose group for material balance study.Urine and fecal samples were collected in the 20mg dose group for material balance study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 were aged 18-45 years (including boundary values), male and female.
- •Weight ≥50kg (male) or ≥45kg (female), and body mass index (BMI) of 19-24kg/m2 (including the boundary values at both ends).
- •Have fully understood this study, voluntarily participated in it, and signed the Informed Consent.
- •Subjects are able to communicate well with researchers and complete the study according to protocol.
- •The subjects were deemed to be in good health based on physical examination, medical history, vital signs, electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests.
- •Subject (including partner) is willing to have no pregnancy plan for the next 30 days (female subject) or 90 days (male subject) and is willing to use effective contraception.
排除标准
- •Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
- •The patient has symptoms or related history of any serious disease, including but not limited to heart, liver, kidney, or other acute or chronic digestive tract or respiratory tract diseases, as well as diseases of the blood, endocrine, neurological, psychiatric and other systems, or any other disease or physiological condition that can interfere with the study results.
- •A history of postural hypotension with frequent episodes.
- •A history of frequent nausea or vomiting due to any cause.
- •Any clear history of drug or food allergies, especially allergies to ingredients similar to the drugs in this study.
- •Have special dietary requirements and cannot comply with the uniform diet provided by the clinical research center.
- •Previous drug abuse history or positive urine drug screening during screening period.
- •Smokers who smoked more than 5 cigarettes a day in the 3 months before the test.
- •Heavy drinkers or regular drinkers in the 6 months prior to the study screening, who drank more than 14 units of alcohol per week (1 unit of alcohol ≈360 mL beer or 45 mL 40% spirits or 150 mL wine) or had a positive alcohol breath test during the screening period.
- •Excessive consumption of tea, coffee (more than 6 cups) and/or caffeinated beverages (more than 1L) per day.
- •Surgical procedures, transfusions of blood or blood components in the month prior to study screening.
- •Blood loss or donation of more than 400 mL in the 2 months prior to screening.
- •Participated in other clinical studies and took experimental drugs within 3 months prior to study screening.
- •Study participants who had received any medication in the 28 days prior to screening.
- •Pregnant or lactating women or women who have had unprotected sex within 14 days.
- •Those unable to complete the study for other reasons or deemed unsuitable for inclusion by the researcher.
研究组 & 干预措施
AD16
The experimental group received AD16, which was a tablet with a dosage form of 10mg/tablet. Take warm water orally on an empty stomach in the morning, once a day.7 dosing cohorts will receive a single oral dose of AD16.
干预措施: AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg (Drug)
placebo
The placebo group received AD16 placebo, which was a tablet with a dosage form of 10mg/tablet. Take warm water orally on an empty stomach in the morning, once a day.
7 dosing cohorts will receive a single oral dose of AD16 placebo.
干预措施: AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg (Drug)
结局指标
主要结局
Adverse events
时间窗: day-7 to day3
The number of adverse events
Serious adverse events
时间窗: day-7 to day3
The number of serious adverse events
Number of participants with abnormal physical examination findings
时间窗: Screening period (day-7 to day-2) and day3
The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.
Concomitant Medication
时间窗: up to day3
Any concomitant medication
Tmax of AD16
时间窗: day1 to day3
Time to reach the maximum (peak) plasma concentration following drug administration
Cmax of AD16
时间窗: day1 to day3
Maximum (peak) plasma drug concentration
t1/2z of AD16
时间窗: day1 to day3
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Number of participants with abnormal vital signs
时间窗: day-7 to day3
Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Number of participants with abnormal laboratory test results
时间窗: Screening period (day-7 to day-2) and day3
Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine
Number of participants with abnormal 12-lead electrocardiogram readings
时间窗: Screening period (day-7 to day-2) and day3
abnormal 12-lead electrocardiogram readings
AUC 0-∞ of AD16
时间窗: day1 to day3
AUC 0-∞ is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time). area under curve(AUC)
λz of AD16
时间窗: day1 to day3
Terminal disposition rate constant/terminal rate constant
AUC 0-t of AD16
时间窗: day1 to day3
AUC 0-t is defined as the concentration of drug from time zero to the last quantifiable concentration.area under curve(AUC)
CL/F of AD16
时间窗: day1 to day3
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). administration
Vd/F of AD16
时间窗: day1 to day3
Apparent volume of distribution after non-intravenous administration
Mean retention time（MRT ）of AD16
时间窗: day1 to day3
Mean retention time from first dosing to t hours or mean retention time from first dosing to infinity
次要结局
- Fe0-t(day-3 to day3)
- Ae(day-3 to day3)
- Renal clearance(day-3 to day3)