Safety, Tolerability and Pharmacokinetics of AD16 Tablets After Multiple Administration in Healthy Chinese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This single-center, randomized, placebo-controlled, double-blind, dose-increasing study was designed to evaluate the safety, tolerability, and pharmacokinetics of multiple successive dosing in healthy Chinese adult subjects.In this study, 20 healthy adult subjects were enrolled in a multi-dose study in the 30mg and 40mg groups.
详细描述
In this study, subjects were given multiple doses in the corresponding dose group
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 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.
- •Take food or drink rich in xanthine, grapefruit or alcohol, caffeine (e.g., dragon fruit, mango, grapefruit, chocolate, coffee or tea) within 48 hours before administration.
- •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
研究组 & 干预措施
AD16
AD16 tablets should be administered only in the morning on the day of the first dose and on the ninth day after the first dose. Fasting is required for at least 10 h before administration.Two dosing cohorts received AD16 From the third day to the eighth day, the medicine was administered twice a day, 1 h before breakfast, 1 h before dinner or 2 h after dinner, with a 12 h interval (time window ±1 h).The duration of oral AD16 tablets was nine days.
干预措施: AD16 30mg、40mg (Drug)
AD16 placebo
AD16 placebo tablets should be administered only in the morning on the day of the first dose and on the ninth day after the first dose. Fasting is required for at least 10 h before administration.Two dosing cohorts received AD16 placebo From the third day to the eighth day, the medicine was administered twice a day, 1 h before breakfast, 1 h before dinner or 2 h after dinner, with a 12 h interval (time window ±1 h).The duration of oral AD16 placebo tablets was nine days.
干预措施: AD16 Placebo 30mg、40mg (Drug)
结局指标
主要结局
Adverse events
时间窗: day-7 to day11
The number of adverse events
Serious adverse events
时间窗: day-7 to day11
The number of serious adverse events
Number of participants with abnormal laboratory test results
时间窗: Screening period (day-7 to day-2) and day11
Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine, etc.
Number of participants with abnormal vital signs
时间窗: Screening period（day-7 to day-1）、days1、4、5、6、8、9
Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Number of participants with abnormal physical examination findings
时间窗: Screening period（day-7 to day-2）、days11
The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.
Number of participants with abnormal 12-lead electrocardiogram readings
时间窗: Screening period（day-7 to day-2）、days1、6、11
Abnormal12-lead electrocardiogram
Concomitant medication
时间窗: Up to day 11
Any concomitant medication
次要结局
- AUC 0-t of AD16(Up to day 11)
- Vd/F of AD16(Up to day 11)
- CL/F of AD16(Up to day 11)
- λz of AD16(Up to day 11)
- AUC 0-48h of AD16(Up to day 11)
- AUC_%Extrap of AD16(Up to day 11)
- Tmax,ss of AD16(Up to day 11)
- Cmax, ss of AD16(Up to day 11)
- Cavg,ss of AD16(Up to day 11)
- t1/2,ss of AD16(Up to day 11)
- AUC 0-τ,ss of AD16(Up to day 11)
- AUC 0-48h,ss of AD16(Up to day 11)
- AUC 0-∞,ss of AD16(Up to day 11)
- CL/F,ss of AD16(Up to day 11)
- Tmax of AD16(Up to day 11)
- Cmax of AD16(Up to day 11)
- t1/2z of AD16(Up to day 11)
- AUC 0-∞ of AD16(Up to day 11)
- Rac of AD16(Up to day 11)
- DF of AD16(Up to day 11)
- Vd/F,ss of AD16(Up to day 11)