Randomized, Double-blind and Placebo-controled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of ZX-7101A and Its Food Effect in China Healthy Adult Volunteers

Nanjing Zenshine Pharmaceuticals1 个研究点分布在 1 个国家目标入组 66 人开始时间: 2021年12月1日最近更新: 2023年7月21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: 66
试验地点: 1
主要终点: Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)

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

Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending doses of ZX-7101A tablet. Part 2 is to assess the food effect on ZX-7101A at a selected dose in a cross-over design.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

盲法说明

double-blind, placebo-controled study

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 adults age of 18-45 years old
•BMI in the range of 9~26 kg/m2; Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg
•In the judgement of the investigator, no clinically relevant abnormalities identified by a detailed medical history and full physical examination including BP and pulse rate measurement, or clinical laboratory tests
•Female subjects of nonchildbearing potential must be not pregnant or lactating. Subjects must consent and comply with the contraception requirement of the study.
•Able to understand the risks involved in the study, and provide written informed consent before the first study-specific procedure
•Able to understand and comply with the study procedures

排除标准

•History of hypersensitivity or allergy to drug or food
•History of clinically significant abnormalities such as metabolic, liver, kidney, blood, lung, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disorders; or in the judgement of the investigator, any medical abnormality that may be a concern to participate the study.
•Tympanic temperature >37.5℃, Pulse >100bmp or <50bmp, Systolic blood pressure ≥140mHg or ≤90mHg, or Diastolic blood pressure ≥90mHg or<50mHg
•Clinically relevant out-of-range baseline of total white cells or absolute neutrophil count
•Total bilirubin >1.5x ULN, AST >1.5 ULN or ALT >1.5ULN
•Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2
•QTc interval > 450ms （ Fridericia's correction ， QTcF=QT/(RR^0.33) ）, QRS>120ms
•Acute respiratory tract infection within 2 weeks
•Any condition possibly affecting drug absorption, e.g. gastrectomy
•Received treatment of any prescription drug or alternative medicine within 4 weeks before first dosing or any nonprescription drug within 2 weeks or 5x half-life, whichever is longer
•Regular alcohol consumption >14units/week I the past 6 months or positive in alcohol breath test
•Use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day within 3 months
•Unwilling or unable to restrict the intake of caffeine or alcohol within 72 hours before dosing or during the in-patient observation period
•Use or intake of any known liver enzyme inducer or inhibitor within 14 days
•History of drug abuse or positive urine drug test
•Positive test for Hepatitis C antibody (HCV), Hepatitis B surface antigen (HbsAg), Human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening
•Accumulative blood donation >400ml within 3 months or >200ml within 4 weeks or planning to donate during the study
•Pregnancy or lactating at screening
•Having difficulty of drawing blood from vein
•Treatment with an investigational drug or procedure within 3 months
•Received vaccination within 3 months or plan to be received vaccine during the study
•Received any surgical procedure within 3 months at screening
•Any other reason that, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.