A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Adverse events of the single ascending-dose
研究概览
简要总结
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
详细描述
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.
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
- •Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- •Able to complete the study according to the protocol;
- •Between 18 and 45 years of age, inclusive, male subject should be no fertility needs;
- •Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2, inclusive;
- •Physical examination and vital signs without clinically significant abnormalities.
排除标准
- •Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
- •Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- •Donated blood or massive blood loss within 3 months before screening (>450 mL）;
- •Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
- •Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening;
- •Have participated in any clinical trial or taken any study drug within 3 months before dosing;
- •Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
研究组 & 干预措施
50 mg single dose
It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: HEC74647PA Capsule (Drug)
50 mg single dose
It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: placebo (Drug)
100 mg single dose
Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: HEC74647PA Capsule (Drug)
100 mg single dose
Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: placebo (Drug)
200 mg single dose
Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.
干预措施: HEC74647PA Capsule (Drug)
200 mg single dose
Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.
干预措施: placebo (Drug)
400 mg single dose
Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: HEC74647PA Capsule (Drug)
400 mg single dose
Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: placebo (Drug)
600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: HEC74647PA Capsule (Drug)
600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: placebo (Drug)
800 mg single dose
Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: HEC74647PA Capsule (Drug)
800 mg single dose
Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
干预措施: placebo (Drug)
100 mg multiple doses
Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
干预措施: HEC74647PA Capsule (Drug)
100 mg multiple doses
Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
干预措施: placebo (Drug)
200 mg multiple doses
Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
干预措施: HEC74647PA Capsule (Drug)
200 mg multiple doses
Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
干预措施: placebo (Drug)
400 mg multiple doses
Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
干预措施: HEC74647PA Capsule (Drug)
400 mg multiple doses
Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
干预措施: placebo (Drug)
结局指标
主要结局
Adverse events of the single ascending-dose
时间窗: Baseline to day 6~13
To assess the tolerability after a single dose of HEC74647PA capsule
Adverse events of the multiple ascending-dose
时间窗: Baseline to day 12
To assess the tolerability after multiple doses of HEC74647PA capsule
Tmax
时间窗: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Time of the maximum observed plasma concentration
T1/2
时间窗: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Terminal elimination half-life
Vz/F
时间窗: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Apparent volume of distribution
CL/F
时间窗: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Oral clearance
MRT
时间窗: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Mean Residence Time
AUC
时间窗: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Area under the plasma concentration-time curve (AUC)
Cmax
时间窗: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Maximum observed plasma concentration of HEC74647
次要结局
未报告次要终点