A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Jiashen Tablets in Healthy Subjects

Tasly Pharmaceutical Group Co., Ltd1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2020年6月29日最近更新: 2022年11月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Tasly Pharmaceutical Group Co., Ltd
入组人数: 70
试验地点: 1
主要终点: Number of participants with abnormal blood pressure (BP)

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

Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and multiple ascending dose of Jiashen Tablets.

详细描述

This study will include a randomized, double-blind, placebo-controlled, single ascending dose design study (Part A), and an open-label SDAD pre-multiple daily ascending dose (MDAD) study (Part B) and an open-label MDAD study (Part C) study.

The study will be conducted in healthy participants and performed at a single study center. 70 healthy participants are planned to be included in the study.

Part A will include six cohorts, 40 participants. Within each cohort, 2 participants will be randomized to receive placebo and other participants randomized to receive Jiashen Tablets. Each participant will receive Jiashen Tablets at the selected dose level or placebo by oral administration in a fasted state once daily.

Part B will include two cohorts, 6 participants, minimum dose group and maximum dose group respectively depending on the findings. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily.

Part C will include three cohorts, 24 participants. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily for 7 days.

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)

盲法说明

Part A is double-blind with regard to treatment (Jiashen Tablets or placebo) at each dose level. Jiashen Tablets and placebo will be matched for formulation, appearance, and amount. Part B and Part C are open-label with regard to treatment (Jiashen Tablets) at each dose level.

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy volunteers, half male and half female, aged 18-50 years (including the boundary value), the age difference of the same batch of subjects should not exceed 10 years.
•Have a body mass index of all subjects between 19 and 24kg /m2 (inclusive) and weight of the male subject should be no less than 50Kg and the weight of the female subject should be no less than 45Kg.
•Passed the smoke test, alcohol and drug abuse test, general physical examination and laboratory examination, chest film, ultrasound, electrocardiogram and other physical and chemical tests.
•No history of major diseases, no history of smoking and drinking, negative blood pregnancy test of women of childbearing age and no lactation.
•Obtain informed consent and volunteer to be tested in accordance with the provisions of the Drug clinical trial quality management standard.

排除标准

•Have primary diseases of cardiovascular，hepatic or renal disease or any other condition. With history of digestive tract diseases, metabolic diseases, and neurological diseases.
•QTc extension (male >430ms, female >450ms).
•History of drug allergy or allergic constitution.
•Family history of hypokalemia, long QT syndrome or other TdP risk factors.
•Mentally or physically disabled.
•Any clinically significant abnormalities in physical examination, biochemical and hematuria routine examination, electrocardiogram, chest film and ultrasound examination,.
•Any positive result on Screening for serum hepatitis B tests (except surface antibodies), hepatitis C antibody , human immunodeficiency virus (HIV) and treponema pallidum antibody test.
•Those who had taken a drug known to damage an organ within 3 months, taken any drug within 2 weeks, and participated in other clinical trials within 4 weeks.
•Bleeding tendency.
•Women during menstruation, pregnancy and lactation.
•Abnormal vital signs (systolic pressure <90mmHg or >140mmHg, diastolic pressure <60mmHg or >90mmHg;Heart rate <60bpm or >100bpm).
•Have smoked more than one cigarette per day or used a considerable amount of nicotine products within the previous 3 months, and could not quit smoking during the experiment. Positive screen for the smoke test.
•Regular drinkers who drank more than 14 units of alcohol per week (1 unit =360mL beer or 45mL spirits with a 40% alcohol content or 150mL wine) during the 6 months prior to the trial, or who tested positive for alcohol, or who do not abstain during the trial.
•Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) or caffeine test positive.
•Have a history of blood transfusion or donation in the last 3 months (blood volume greater than 200mL).
•Have a history of drug abuse and tested positive for drug abuse (morphine, methamphetamine, ketamine, dimethyldimethamphetamine, THC, cocaine).
•Have a history of antibiotic use in the last month.
•Have taken lactobacillus products (including yogurt) in the last week.
•Judgment by the Investigator that the participant should not participate in the study (such as weak, etc).

干预措施: Jiashen Tablets Placebo (Drug)

结局指标

主要结局

Number of participants with abnormal blood pressure (BP)

时间窗: From screening (Day-7) till follow-up visit (Up to 1 week)

To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants. Blood pressure includes both systolic and diastolic BP.

Number of participants with abnormal respiratory

时间窗: From screening (Day-7) till follow-up visit (Up to 1 week)