Safety and tolerability assessments
SAD
ADVERSE EVENTS
Safety and tolerability assessments included adverse events (AEs) and serious AEs (SAEs) assessments from the signing of ICF until finishing assessments in the last visit of follow-up. Time intervals between the last dose and last visit of follow-up in SAD and MAD stages were both 7 days. Severity of AEs was classified mainly according to the protocol of this trial, CTCAE (version 5.0) was also referred to verify the judgment. AEs were coded by the Medical Dictionary for Regulatory Activities (MedDRA) version 25.1 term (MedDRA MSSO, Herndon, VA, 