All the pharmacokinetic samples in the single and multiple dosing tests were collected, centrifuged and packed by the research centre and transported to the testing unit in the frozen state on dry ice (≤−70℃). They were tested and analysed for the plasma concentration using the validated LC‐MS/MS (Waters, UPLC‐Xevo TQ‐S) analysis method, and the quantitative lower limit is 0.22 ng/mL for the SAD and 0.3 ng/mL for MAD. The non‐compartment model (NCA) was used to calculate the pharmacokinetic parameters, and the main parameters obtained were Cmax, Tmax, AUC, t1/2, CL and Vz.
All the ADA samples are transported to the testing unit in the cold chain under dry ice (≤−70℃) and were screened and confirmed with the indirect ELISA analysis method, and the positive samples were tested for the antibody titre.