重组人源化抗人IL-6R单克隆抗体BAT-1806注射液单次给药药代动力学研究

Objective:To study the pharmacokinetics of BAT-1806 after a single intravenous injection in cynomolgus monkeys, and carry out conformance comparison with TOC.Methods:Twenty four cynaomolgus monkeys were randomly divided into four groups according to their body mass, half female and half male.They were given single doses of 10 and 30 mg·kg^-1 of BAT1806 injection or TOC injection.Blood samples were collected at different time points and the plasma concentrations were determined by ELISA.The data obtained were subjected to noncompartment pharmacokinetic analysis using WinNonlin software.Pharmacokinetic parameters were compared and the bioequivalence between BAT1806 and TOC was evaluated.Results:After given a single intravenous injection of BAT-1806 with 10 mg·kg^-1 or 30 mg·kg^-1, T_max was(0.58±0.38) h and(0.25±0.42) h, T_1/2 was(81.6±54.5) h and(105.7±30.2) h, C_max was(202 415±39 064) ng·mL^-1 and(613 161±133 207) ng·mL^-1, AUC_(0-t) was(17 614 098±3 716 972) h·ng·mL^-1 and(55 333 524±16 351 767) h·ng·mL^-1, V_d was(66.6±37.5) mL·kg^-1 and(84.3±21.8) mL·kg^-1, Cl was(0.58±0.13) mL·h^-1·kg^-1 and(0.58±0.16) mL·h^-1·kg^-1, MRT was(107.8±15.5) h and(177.2±28.6) h, respectively.There was no gender difference in the pharmacokinetic characteristics of BAT-1806 in cynomolgus monkeys.There was no significant difference in the main pharmacokinetic parameters between BAT-1806 and TOC, indicating that the pharmacokinetic characteristics of the two drugs are consistent.The C_max and AUC_(0-t) ratios of the 10 mg·kg^-1 BAT-1806 and TOC were 0.98 and 1.05, respectively, and the C_max and AUC_(0-t) ratios of 30 mg·kg^-1 BAT-1806 and TOC were 0.98 and 0.92.Conclusion:The pharmacokinetic characteristics of the BAT1806 or TOC are conformable and bioequivalent.

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