Safety Assessment
Vital signs will be measured at various time points (1, 3, 6, 8, 12, 24, 72, 120, 168 hours) before and after drug administration. Medical staff will closely monitor and report adverse events throughout the trial. Safety assessment was conducted throughout the entire study period, and laboratory examinations, physical examinations, 12-ECG were performed before dosing and after blood sampling.
On the one hand, all the AEs were evaluated and recorded pertaining to seriousness, intensity, time course, outcome, relationship to the study formulation [8]. On the other hand, AEs were coded to a preferred term and system organ class according to the Medical Dictionary for Regulatory Activities [8]. All clinical occurrences and clinically meaningful laboratory adverse reactions will be evaluated according to the Common Adverse Events Evaluation Criteria (CTCAE) version 4.03. To reveal the relationship between AEs and formulations, five description types were documented (not relevant, unlikely, possible, probable, or definitely relevant).