Comparative Study of QL1209 and Perjeta® in Healthy Male Participants

Trial participants with a history of or currently having any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematological, immunological, psychiatric and metabolic disorders, or any other diseases that may interfere with the study results, or participants with clinically significant allergic reactions or allergic constitution, angioedema, interstitial pneumonitis or acute respiratory distress syndrome;

Participants with abnormal vital signs (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; heart rate < 50 bpm or > 100 bpm) or clinically significant abnormalities in physical examination, ECG and laboratory tests (participant to the judgment of clinicians), and those whose LVEF is beyond the normal range as shown by echocardiography; Adult males with a left ventricular ejection fraction (LVEF) outside the normal reference range of 52% to 72%, as defined by the American Society of Echocardiography (ASE), will be excluded;

Any clinically relevant laboratory findings that, in the opinion of the Investigator, would preclude inclusion in the trial; including alanine aminotransferase (ALT) >1.1 × upper limit of normal (ULN), aspartate aminotransferase (AST) >1.2 × ULN, bilirubin (total) >1.5 × ULN. Participants with estimated glomerular filtration rate (eGFR) based on Cockcroft-Gault equation < 90 mL/min/1.73 m2 will be excluded. If any of these tests are out-of-range, the tests can be repeated once;

QT interval corrected for heart rate using Fridericia's correction (QTcF) > 450 msec.