Randomized, Double-blind, Placebo-controlled, Single-dose Ascending Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7450 in Healthy Subjects.

Fujian Shengdi Pharmaceutical Co., Ltd.0 个研究点目标入组 50 人开始时间: 2023年10月最近更新: 2023年10月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Fujian Shengdi Pharmaceutical Co., Ltd.
入组人数: 50
主要终点: Adverse Events (AEs)

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记录与标识符相似试验

研究概览

简要总结

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending doses of HRS-7450 given to healthy subjects, compared to placebo..

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)

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

•Healthy male and female subjects between 18 and 45 years of age (inclusive) at the screening visit
•Female weighed ≥ 45 kg, male weighed ≥ 50 kg, and all weighed ≤ was 90 kg, and a BMI between 18-28 kg/m²(inclusive)
•Subjects with fertility promised to have no fertility, sperm or egg donation plan and voluntarily take efficient contraceptive measures ( including partners ) within two weeks before screening and 6 months after the last administration
•Able to provide written, informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the Principal Investigator, to comply with all the requirements of the trial

排除标准

•Subjects with a history of drug allergy, or a history of allergy ( asthma, urticaria, eczema, etc. ), or allergic constitution ( such as allergies to two or more drugs, food, and pollen ) or intolerance to any ingredients of the study drug
•Subjects with heart, respiration, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood, nervous system disease or mental illness, metabolic dysfunction prior to screening or administration
•The results of physical examination, vital sign examination, laboratory examination, etc. during the screening are deemed clinically significant
•Subjects with risk factors for torsades de pointes ventricular tachycardia, or had a family history of short QT syndrome, long QT syndrome, unexplained sudden death in youth ( ≤ 40 years old ), drowning or sudden infant death syndrome in first-degree relatives ( i.e., biological parents, siblings or children )
•Subjects with hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia are deemed clinically significant
•ECG examination is clinical significant, such as QTcF > 470ms
•Subjects with gastrointestinal, urinary and other bleeding tendencies or other high-risk bleeding tendencies within 3 weeks before screening; or those who have arterial puncture within the past 1 week that does not easily compress the hemostatic site were included
•ALT, AST, total bilirubin, direct bilirubin and indirect bilirubin exceeded the upper limit of normal value during screening visit
•Positive test for human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) or syphilis at the Screening Visit.
•Subjects who underwent surgery within 3 months before screening or schedule to have surgery during the trial, or those who have previously had surgery that may affect the PK profile or safety evaluation significantly of the study drug
•Subjects who received any IMP within 3 months before the screening visit or planned to participate in other clinical trials during the trial
•Received any drug that inhibits or induces liver metabolism of the drug within 1 month prior to screening visit
•Received any prescription drugs (including vaccines) or non-prescription medications, and herbal supplements within 2 weeks prior to screening visit
•Blood donation or blood loss≥200 mL within 3 month before screening, or schedule to donate blood during the trial or within 1 month after the end of the trial.
•Had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (averaging more than 8 cups per day of 200 ml each) in the 2 weeks prior to screening visit
•History of alcohol abuse [more than 14 units of alcohol intake in one week (1 unit of alcohol equivalent to 285 mL of beer, 25 mL of spirits, or 100ml of wine), more than twice a week]
•More than 10 cigarettes( or equivalent tobacco)per day in the 3 months prior to screening or unable to quit smoking during the trial period
•Positive urine drug test at the Screening Visit History of drug abuse within the past 5 years
•Pregnant or lactating women, or pregnancy test positive
•Can not tolerate venipuncture or have a history of needle sickness and blood
•Subjects with history of phlebitis
•In the opinion of the Investigator, subjects should be excluded in this trial