A Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Study Evaluating the Pharmacokinetics and Safety of GFH312 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The apparent volume of distribution during the terminal elimination phase (Vd/F) following extravascular administration of GFH312
研究概览
简要总结
The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects.
详细描述
This study was planned to enroll about 26 healthy subjects, subjects were planned to receive single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily participate in the study and sign the informed consent;
- •Male or female healthy subjects aged 18-55 years (inclusive) (single sex ratio not less than 25% of the sample size of each cohort);
- •Body mass index (BMI) between 18-28 kg/m2 (inclusive), and weight ≥ 50kg; BMI = Weight (kg) /[Height (m)]
- •During the screening period and day 1, patients with normal or abnormal results but no clinical significance based on detailed medical history, comprehensive physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and vital signs.
- •Able to communicate well with researchers, understand and comply with research requirements.
排除标准
- •Any procedure or disease that may significantly alter drug absorption, distribution, metabolism, or excretion, or participation in this study may compromise the safety of the subject.
- •Tuberculin test positive
- •Abnormal electrocardiogram with clinical significance
- •Use any prescription drugs, Chinese herbs and/or OTC or health products within 2 weeks before starting the administration.
- •Women who are pregnant or breastfeeding, or subjects with positive pregnancy test results at the time of screening or at baseline, or who plan to become pregnant during the study period or within 30 days after the end of the study.
- •Subjects who have any factors deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
SAD:100mg
Participants received single PO dose of GFH312 100 mg.
干预措施: GFH312 100 mg (Drug)
SAD:200mg
Participants received single PO dose of GFH312 200 mg.
干预措施: GFH312 200 mg (Drug)
MAD:120mg
Participants received multiple PO doses of GFH312 120 mg for 14 days.
干预措施: GFH312 120mg (Drug)
Placebo
Participants receiving placebo matching with the GFH312 dose groups
干预措施: Placebo (Other)
结局指标
主要结局
The apparent volume of distribution during the terminal elimination phase (Vd/F) following extravascular administration of GFH312
时间窗: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The volume of distribution was estimated based on the plasma concentrations of GFH312
The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state (Cmin,ss)
时间窗: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Observed minimum concentration in the dosing interval at steady state.
Time to reach maximum concentration in the dosing interval at steady state (Tmax,ss)
时间窗: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
If the same Cmax concentration occurs at different time points, Tmax is assigned to the first occurrence of Cmax.
The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau (AUCtau,ss)
时间窗: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Dose-normalized AUC0- τ, calculated as AUC0-τ divided by actual dose administered.
Maximum Observed Plasma Concentration (Cmax) of GFH312
时间窗: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of GFH312.
Time to peak drug concentration (Tmax) of GFH312
时间窗: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The time it takes for a drug to reach the maximum concentration (Cmax) after administration of GFH312
Terminal Elimination Half Life (t1/2) of GFH312
时间窗: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of GFH312
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of GFH312
时间窗: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of GFH312
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of GFH312
时间窗: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of GFH312
The apparent systemic (or total body) clearance from plasma (or serum or blood (CL/F) following extravascular administration of GFH312
时间窗: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
The systemic clearance (CL) was estimated based on the plasma concentrations of GFH312
The observed maximum plasma (or serum or blood) concentration following drug administration at steady state (Cmax,ss)
时间窗: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Observed maximum concentration in the dosing interval at steady state
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(up to 30 days after the last study drug administration)