临床试验/NCT04161547

NCT04161547已完成1 期

A Phase I, Ascending Multiple-dose Clinical Trial of CSPCHA115 Capsules to Evaluate the Tolerability and Pharmacokinetics in Chinese Healthy Volunteers

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2019年12月12日最近更新: 2021年4月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 40
试验地点: 1
主要终点: Number of subjects with clinically significant electrocardiograms (ECGs) abnormalities

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A randomized, single-center, double-blind, ascending multiple-dose, placebo-controlled study to evaluate the tolerability and pharmacokinetics of CSPCHA115 capsules in Chinese healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
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

•18 ≤ age ≤ 45 years old, male or female;
•Bodyweight≥45.0 kg (female) or 50.0 kg (male), 19 kg/m^2 ≤ Body Mass Index（BMI ）≤ 26 kg/m^2;
•The female subjects are not during pregnancy or lactation; the male subjects have no sperm donation plan from the signing of the informed consent form to 1 month after the completion of the study. The subjects and their partners agree to use effective non-hormonal contraceptives (such as condoms, drug-free IUDs, etc.) from the day signing the informed consent form to 1 month after the completion of the study, or had taken permanent contraceptives (such as bilateral tubal ligation, vasectomy, etc.);
•Subjects voluntarily sign the informed consent form, and are able to complete the trial according to the protocol;

排除标准

•Those who conform to one of the following provisions shall not be included in the group;
•A clear history of neurological or mental disorders (including seizures, dementia, depression or biphasic affective disorders, etc.); immunodeficient or immunosuppressive diseases, malignant tumor diseases; cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive system and other chronic diseases;
•Subjects who underwent large surgical operations within 6 months before signing the informed consent (such as coronary artery bypass grafting, hepatorenectomy, nephrectomy, gynecological surgery, etc.), and those with acute neurological, digestive, respiratory, circulation, endocrine, blood and other systemic diseases within 3 months before signing the informed consent form may affect the absorption, distribution, metabolism and excretion of drugs;
•Subjects with allergic constitutions, or who are allergic to more than 1 drug, or had other known serious allergic reactions;
•Subjects who did not meet the health criteria during the screening period, including abnormal vital signs; QTc interval ≥ 450 ms (male) or 470ms (female), prolongation of QTc interval, or other abnormal clinical significance of electrocardiogram (ECG); the results of physical examination, laboratory examination and so on are abnormal and have clinical significance.
•One of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) and Treponema pallidum antibody (Anti-TP) was positive;
•Any prescription drugs, non-prescription drugs, biological products, the Chinese patent medicines, herbs, vitamin dietary supplements, and health-care products (other than external use), oral long-acting contraceptives or embedded long-acting contraceptives were used regularly within 2 weeks before the signing of the informed consent form;
•A history of alcoholism, or alcohol test positive at screening;
•The average daily smoking volume was more than 5 within 6 months before signing the informed consent form;
•Drug abuse within 1 year before signing the informed consent form, or urine test positive for drugs at screening;
•Subjects who were accustomed to excessive caffeine drinks or foods that may affect drug metabolism within 4 weeks prior to the signing of the informed consent form;
•Subjects who lost blood or donated more than 200 ml within 8 weeks before signing the informed consent form, or who planned to donate blood within 1 month after the completion of the study;
•Subjects who plan to undergo surgery during the trial period, or those who plan to take part in strenuous exercise during the trial period;
•Subjects who are participating in other clinical trials, or who have participated in clinical trial about any other drugs or devices within 3 months before signing the informed consent form;
•Not suitable for this clinical trial judged by the investigators.

研究组 & 干预措施

Cohort A1: CSPCHA115 100 mg

Experimental

CSPCHA115 100 mg or placebo administered orally in the fasted state for 7 days.

Eight subjects will receive CSPCHA115
Two subjects will receive matching placebo

干预措施: CSPCHA115 100 mg; Matching placebo 100 mg (Drug)

Cohort A2: CSPCHA115 200 mg

Experimental

CSPCHA115 200 mg or placebo administered orally in the fasted state for 7 days.

Eight subjects will receive CSPCHA115
Two subjects will receive matching placebo

干预措施: CSPCHA115 200 mg; Matching placebo 200 mg (Drug)

Cohort A3: CSPCHA115 400 mg

Experimental

CSPCHA115 400 mg or placebo administered orally in the fasted state for 7 days.

Eight subjects will receive CSPCHA115
Two subjects will receive matching placebo

干预措施: CSPCHA115 400 mg; Matching placebo 400 mg (Drug)

Cohort A4: CSPCHA115 600 mg

Experimental

CSPCHA115 600 mg or placebo administered orally in the fasted state for 7 days.

Eight subjects will receive CSPCHA115
Two subjects will receive matching placebo

干预措施: CSPCHA115 600 mg; Matching placebo 600 mg (Drug)

结局指标

主要结局

Number of subjects with clinically significant electrocardiograms (ECGs) abnormalities

时间窗: 10 days after drug administration

To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Number and incidence of subjects with Adverse Events (AEs)

时间窗: 12 days after drug administration

To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Number of subjects with clinically significant vital sign abnormalities

时间窗: 10 days after drug administration

To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Tmax at steady state (Tss max)

时间窗: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Cmin at steady state (Css min)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Number of subjects with clinically significant laboratory abnormalities

时间窗: 10 days after drug administration

To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Time to reach maximum observed concentration (Tmax)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Maximum observed concentration (Cmax)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Area under the concentration-time curve from time 0 to 24h (AUC0-24h)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Number of subjects with clinically significant symptoms abnormalities

时间窗: 10 days after drug administration

To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Number of subjects with clinically significant physical examination abnormalities

时间窗: 10 days after drug administration

To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Cmax at steady state (Css max)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Apparent volume of distribution (Vz/F)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Average concentration at steady state (Css av)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Fluctuation coefficient (DF)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Accumulation ratio (Rac)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

AUC at steady state (AUCss)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Elimination half-life (t1/2)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Apparent clearance at steady state (CLss/F)

To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

次要结局

未报告次要终点

研究者

发起方

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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