A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics of Oral SHR2150 in Healthy Subjects With Single Dose of SHR2150 in Healthy Subjects

Jiangsu HengRui Medicine Co., Ltd.1 个研究点分布在 1 个国家目标入组 37 人开始时间: 2021年3月22日最近更新: 2021年12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: Jiangsu HengRui Medicine Co., Ltd.
入组人数: 37
试验地点: 1
主要终点: The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0.

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

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150.

will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule 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: Other
盲法: Double (Participant, Investigator)

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

•Signed informed consent.
•Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between 18 to 28 kg/m2 ( Including boundary value) .
•Vital signs, physical examination, laboratory results are within normal range or considered not clinically significant.
•Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.

排除标准

•Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
•Have severe infection, severe trauma or major surgical operations within 3 months. Plan to receive surgery during the trial and within two weeks after the end of the trial..
•12-ECG test have clinical significant abnormality or the QT interval (QTc) > 450 ms(male)/QTc)> 460 ms(male) or<300ms(female).
•Screening for infectious diseases is positive (Including HBsAg, Anti-HCV, TPPA, Anti-HIV)
•Suspected allergy to any ingredient in the study drug.
•Have any drug that inhibits or induces liver metabolism within 1 month.
•Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug judged by the investigator;
•Treatment with immunosuppressant or interferon-containing drugs within 6 months of study drug administration;
•Participated in clinical trials of any drug or medical device within 3 months before screening, or within 5 half-lives before screening;
•Treatment with live(attenuated) vaccine within 2 months before taking the study drug or during the study or within 1 months after administration;
•Had donated blood or blood transfusion≥ 200 mL within 1 months before taking the study drug or had donated blood or blood transfusion≥ 400 mL within 3 months prior to screening;
•The average daily smoking ≥ 5 cigarettes within three months; the average daily alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol);
•Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the study; and those who have special dietary requirements and cannot follow the unified diet;
•History of drug abuse , drug dependence or drug screening test is positive;
•Pregnant or lactating women;
•Other conditions that the investigator believes the subject is not suitable.