A randomized, double-blind, placebo-controlled dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AND017 following oral single and multiple dose administration

BalanceBio Pty Ltd0 个研究点目标入组 78 人开始时间: 2020年7月7日最近更新: 2020年7月13日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 78

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 45 Years（—）
性别: All

入选标准

•Each subject must meet the following criteria to be enrolled in this
•1. Healthy male or female, 18-45 years of age (both inclusive);
•2. Able to give signed written informed consent form;
•3. Able to remain in house for the duration of the study without interruption;
•4. Body mass index (BMI, weight [kg]/height2 [m]2) within 18.0-30.0 kg/m2 (both inclusive);
•5. Blood Pressure (BP) and 12-lead electrocardiogram (ECG) showing
•no clinically significant abnormalities during screening;
•6. Subjects have no clinically significant abnormal values on physical examination, clinical laboratory test, liver function or kidney function;
•7. Agree to completely refrain from consuming alcohol, caffeinated beverages (i.e. tea, coffee, etc.), and tobacco from 24 h pre the 1st dose until the last PK blood sample collection is finished;
•8. If male, a willingness not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation). This criterion applies to males (and/or female partners) who are surgically sterile and must be followed from the time of first study drug administration until 90 days after the final administration of study drug.
•9. If female, be of non-childbearing potential (e.g. post-menopausal as demonstrated by follicle stimulating hormone (FSH) or surgical sterilization i.e., tubal ligation or hysterectomy). Provision of documentation is not required for female sterilization, verbal confirmation is adequate; If of childbearing potential females must use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation).
•10. Negative urine drug screen at screening and Day-1.

排除标准

•Subjects who meet any of the following criteria will be excluded from
•1. History of severe drug (e.g. or asthma induced by aspirin) or excipient allergy, or hypersensitivity to AND017 capsules or other HIF-PHD inhibitors;
•2. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except Gilbert’s syndrome or asymptomatic gallstones), including but not limited to ALT, alkaline phosphatase and bilirubin greater than 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin greater than 35%);
•3. Subjects with Hb: male (less than 120 g/L or greater than 160 g/L), female (less than 110 g/L or greater than 150 g/L);
•4. Subjects with any abnormalities of hematology during screening: Mean corpuscular volume (MCV), platelet count, serum iron, ferritin;
•5. Subjects with the history of medicine or disease to increase the risk of bleeding or disturbance of blood coagulation;
•6. History of deep vein thrombosis, stoke, transient ischemic attack, pulmonary embolism or other thrombosis related condition within the last five years;
•7. History of myocardial infarction, heart failure or acute coronary syndrome;
•8. History of pulmonary artery hypertension;
•9. Evidence of active peptic, duodenal or esophageal ulcer disease at screening;
•10. Subjects with major illness or surgery (except for minor outpatient surgery) within past 3 months prior to screening, or planned surgery during study;
•11. History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinical research unit uses heparin to maintain intravenous cannula patency);
•12. Subjects with intolerance to direct venipuncture;
•13. Known or suspected history of drug abuse within the past 5 years or presence of drug abuse within 3 months before study;
•14. Participation in any clinical study with an investigational drug, biologic or device within 4 weeks or 5 times the half-life of the specific drug/biologics (whichever is longer), prior to dosing;
•15. Donated blood greater than 400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3months of screening; or donated blood greater than 200 mL or significant blood loss equivalent to 200 mL within 1 month prior to screening
•16. Use of any other drug, including over-the-counter medications, herbs, within 14 days prior to the first dose of study medication (except for contraceptive medication in WOCBP);
•17. Take in food or drink beverages which can influence metabolism of liver 7 days prior to the first dose of the study drug (e.g. grapefruit & Seville oranges );
•18. Habitual use of nicotine products or smoking within 3 months (more than 5 cigarettes per day) prior to screening;
•19. History of significant alcohol abuse within 6 months of screening or any indication of regular use of more than 14 units of alcohol per week (1 Unit equal to 360 mL of beer or 45 mL of alcohol 40% or 150 mL of wine) or taking the product containing alcohol 2 days prior to dosing;
•20. Positive screening test for any one or more: serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV;
•21. Malignancy within 5 years within screening visit (except basal cell skin carcinoma);
•22. Subject who is considered unsuitable for participating in the study in the opinion of investigator;
•23. Nursing mothers, pregnancy women

研究者

发起方

BalanceBio Pty Ltd

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