A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- MRT
研究概览
简要总结
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet 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 Kangdaprevir Sodium Tablet 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（18 and 45 are inclusive）;
- •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（18 and 28 are 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 take any drug that changes liver enzyme activity within 1 month before taking the study drug
- •Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days 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.
- •Have taken any alcoholic products within 24 hours prior to taking the study drug
研究组 & 干预措施
50 mg single dose
It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: Kangdaprevir Sodium Tablet (Drug)
50 mg single dose
It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: placebo (Drug)
100 mg single dose
Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.
干预措施: Kangdaprevir Sodium Tablet (Drug)
100 mg single dose
Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) 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)
200 mg single dose
Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: Kangdaprevir Sodium Tablet (Drug)
200 mg single dose
Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: placebo (Drug)
400 mg single dose
Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: Kangdaprevir Sodium Tablet (Drug)
400 mg single dose
Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: placebo (Drug)
600 mg single dose
Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: Kangdaprevir Sodium Tablet (Drug)
600 mg single dose
Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: placebo (Drug)
800 mg single dose
Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: Kangdaprevir Sodium Tablet (Drug)
800 mg single dose
Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
干预措施: placebo (Drug)
100 mg multiple dose
Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
干预措施: Kangdaprevir Sodium Tablet (Drug)
100 mg multiple dose
Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
干预措施: placebo (Drug)
200 mg multiple dose
Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
干预措施: Kangdaprevir Sodium Tablet (Drug)
200 mg multiple dose
Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
干预措施: placebo (Drug)
400 mg multiple dose
Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
干预措施: Kangdaprevir Sodium Tablet (Drug)
400 mg multiple dose
Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
干预措施: placebo (Drug)
结局指标
主要结局
MRT
时间窗: predose to 72 hour after dosing
Mean Residence Time
Vz/F
时间窗: predose to 72 hour after dosing
Apparent volume of distribution
T1/2
时间窗: predose to 72 hour after dosing
Terminal elimination half-life
CL/F
时间窗: predose to 72 hour after dosing
Oral clearance
Adverse events
时间窗: Baseline to day 13
To assess the tolerability after a single and multiple dose of HEC84048
Cmax
时间窗: predose to 72 hour after dosing
Maximum observed plasma concentration of HEC84048
Tmax
时间窗: predose to 72 hour after dosing
Time of the maximum observed plasma concentration of HEC84048
AUC
时间窗: predose to 72 hour after dosing
Area under the plasma concentration-time curve (AUC)
次要结局
未报告次要终点