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).