A Dose-escalation Study of AND017 in Healthy Subjects

Inclusion criteria

• BMI within 18.0-30.0 kg/m2 (inclusive)
• Blood Pressure (BP) and 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities during screening;
• No clinically significant abnormal values in physical examination, clinical laboratory tests, liver function or kidney function;

Exclusion criteria

• Current or chronic history of liver disease or known hepatic or biliary abnormalities, including but not limited to ALT, alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);
• Subjects with Hb: male <120 g/L or >160 g/L, female <110 g/L or >150 g/L;
• Subjects with any abnormalities of hematology during screening: Mean corpuscular volume (MCV), platelet count, serum iron, ferritin;
• Subjects with a history of medical treatment or disease likely to increase the risk of bleeding or disturbance of blood coagulation;
• History of deep vein thrombosis, stoke, transient ischemic attack, pulmonary embolism or other thrombosis-related condition within the last five years;
• History of myocardial infarction, heart failure or acute coronary syndrome;
• Evidence of active peptic, duodenal or esophageal ulcer disease at screening;
• History of pulmonary artery hypertension;
• History of sensitivity to heparin or heparin-induced thrombocytopenia;
• Subjects with major illness or surgery within past 3 months prior to screening, or planned surgery during study;
• Known or suspected history of drug abuse within the past 5 years or presence of drug abuse within 3 months before study;
• Donated blood >400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3months of screening; or donated blood >200 mL or significant blood loss equivalent to 200 mL within 1 month prior to screening.
• 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;