A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
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
- •Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
- •Be able to complete the study according to the trail protocol
- •Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures
- •Male subjects and must be 18 to 45 years of age inclusive
- •Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive
- •Physical examination and vital signs without clinically significant abnormalities.
排除标准
- •Use of >5 cigarettes per day during the past 3 months
- •Allergies constitution ( multiple drug and food allergies)
- •History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
- •Donation or loss of blood over 450 mL within 3 months prior to screening
- •12-lead ECG with clinically significant
- •Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
- •Subjects deemed unsuitable by the investigator for any other reason.
研究组 & 干预措施
800 mg multiple doses
Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
干预措施: HEC110114 tablet (Drug)
100 mg single dose
It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: HEC110114 tablet (Drug)
100 mg single dose
It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: Placebo Oral Tablet (Drug)
300 mg single dose
Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: HEC110114 tablet (Drug)
300 mg single dose
Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: Placebo Oral Tablet (Drug)
600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: HEC110114 tablet (Drug)
600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: Placebo Oral Tablet (Drug)
800 mg single dose
Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (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: HEC110114 tablet (Drug)
800 mg single dose
Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (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 Oral Tablet (Drug)
1000 mg single dose
Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: HEC110114 tablet (Drug)
1000 mg single dose
Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: Placebo Oral Tablet (Drug)
1200 mg single dose
Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: HEC110114 tablet (Drug)
1200 mg single dose
Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: Placebo Oral Tablet (Drug)
1600 mg single dose
Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: HEC110114 tablet (Drug)
1600 mg single dose
Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)
干预措施: Placebo Oral Tablet (Drug)
600 mg multiple doses
Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
干预措施: HEC110114 tablet (Drug)
600 mg multiple doses
Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
干预措施: Placebo Oral Tablet (Drug)
800 mg multiple doses
Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
干预措施: Placebo Oral Tablet (Drug)
1000 mg multiple doses
Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
干预措施: HEC110114 tablet (Drug)
1000 mg multiple doses
Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Adverse Events
时间窗: From Days 1-12
Percentage of Participants with Adverse Events
次要结局
- Cmax(At pre-defined intervals from Days 1-12)
- Cmin(At pre-defined intervals from Days 1-11 for MAD)
- AUC0-∞(At pre-defined intervals from Days 1-12)
- Tmax(At pre-defined intervals from Days 1-12)
- CL/F(At pre-defined intervals from Days 1-12)
- AUClast(At pre-defined intervals from Days 1-12)
- T1/2(At pre-defined intervals from Days 1-12)