Safety assessment
ADVERSE EVENTS, ADVERSE EVENT
The safety was assessed by monitoring vital signs and laboratory tests. Vital signs, such as body temperature, blood pressure, and heart rate, were measured before administration and at 0.5, 1.33, 3.0, 6.0, 12.0, 24.0, 48.0 h after administration in 4 mg/kg group, while at 0.5, 2.0, 4.0, 8.0, 12.0, 24.0, 48.0 h after administration in 6 mg/kg group. Before removal from this study, the subjects would receive physical examination, vital signs assessment (blood pressure, pulse, body temperature), electrocardiogram examination, laboratory examination, including hematology, urinalysis, blood biochemistry, coagulation function, female blood pregnancy. All adverse events onset within 7 half-life of the drug were followed up until they returned to normal or stable. Adverse events (AEs) were recorded, including clinical symptoms and signs, severity, occurrence and end time, duration, treatment measures, and causal relationship to the study drug.