2.3 Study endpoints
The primary endpoints were maximum plasma concentration of SHR2554
(Cmax), area under the plasma concentration-time curve
(AUC) from time 0 to the time of the last quantifiable concentration
(AUC0-t), and AUC from time 0 to infinity
(AUC0-∞), the secondary endpoints included other PK
parameters, such as time to reach Cmax(Tmax), terminal elimination half-life
(t1/2), apparent clearance (CL/F), and apparent volume
of distribution (Vz/F); and safety endpoints, including incidence and
severity of AEs, and evaluation through laboratory tests, physical
examination, vital signs, and 12-lead ECG. The SHR2554 main metabolites
were quantitatively analyzed. All the definitions and calculations were
provided in the supplementary.