Comparison of the Pharmacokinetic Parameters of ASC41, a Randomized, Double-blind, Placebo-controlled in Healthy Subjects After Single and Multiple Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the safety and tolerability of ASC41 in healthy volunteers
研究概览
简要总结
The objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy subjects after single and multiple oral dosing.
详细描述
The purpose of this study was to evaluate the tolerability, safety pharmacokinetics and pharmacodynamic (biomarkers) of ASC41 tables in a randomized, double-blind, placebo-controlled single- and multiple-dose phase I clinical trial in healthy subjects the study. The effects of ASC41 on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) will be observed after repeated administration of ASC41 in healthy 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
- Double (Participant, Care Provider)
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
- •Age 18-45 (including boundary value).
- •Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
- •She is of childbearing potential and is non-pregnant and willing to use adequate contraception from screening (within 30days from the first administration)until one month after the End of Study visit.
- •The pregnancy test of female subjects during the screening period is negative.
- •During the screening period, fasting low-density lipoprotein cholesterol (110mg/dl < fasting (LDL-C) < 190mg/ dL.
- •Those who voluntarily sign the informed consent.
排除标准
- •Patients with a history of thyroid disease or intolerance to beta blockers or abnormal thyroid function indicators during screening;
- •Previous history of fainting, fainting needle or fainting blood for unknown reasons.
- •Previous liver disease, or ALT, ASL and direct bilirubin in screening period exceed the normal range.
- •Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody are tested positive.
- •People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.
- •Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.
- •Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
- •Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
- •Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.
- •In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.
研究组 & 干预措施
Experimental:20mg
ASC41 four tablets (20mg) single oral dose at Day 1.
干预措施: ASC41 (Drug)
Experimental:5mg
ASC41 one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
干预措施: ASC41 (Drug)
Experimental:10mg
ASC41 two tablets (10mg) single oral dose at Day 1.
干预措施: ASC41 (Drug)
Experimental:2mg
ASC41 two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27.
干预措施: ASC41 (Drug)
Experimental:1mg
ASC41 one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
干预措施: ASC41 (Drug)
Placebo:1mg
ASC41 placebo one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
干预措施: ASC41 placebo (Drug)
Placebo:2mg
ASC41 placebo two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27.
干预措施: ASC41 placebo (Drug)
Placebo:5mg
ASC41 placebo one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.
干预措施: ASC41 placebo (Drug)
Placebo:10mg
ASC41 placebo two tablets (10mg) single oral dose at Day 1.
干预措施: ASC41 placebo (Drug)
Placebo:20mg
ASC41 placebo four tablets (20mg) single oral dose at Day 1.
干预措施: ASC41 placebo (Drug)
结局指标
主要结局
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
时间窗: Up to 32 days
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
次要结局
- Cmax of ASC41(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.)
- Tmax of ASC41(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.)
- AUC of ASC41(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.)
- t1/2 of ASC41(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.)
- Vd/F of ASC41(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.)
- CL/F of ASC41(On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.)