Safety assessment
The safety was evaluated by monitoring vital signs, physical
examination, laboratory tests, electrocardiogram(ECG) and adverse events
(AEs) collected after dosing throughout the study. Vital signs,
including body temperature, blood pressure (BP) and heart rate, were
measured at screening, before drug administration and at 2, 4, 6, 8, 12,
24, 36, 48, 72, 96, 144, 168h after administration. Routine laboratory
tests (hematology, urinalysis, serum chemistry and pregnancy test for
females) and 12-lead ECG were conducted at screening and before removal
from the study. The AEs, including all subjective symptoms reported by
subjects and objective signs observed by clinical investigators, were
recorded and assessed for their severity and the correlation with
research drugs.