Two Doses Of Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection (Jiannipai): A Pharmacokinetic And Pharmacodynamic Study

Aim: This clinical trial was performed to evaluate the pharmacokinetics and pharmacodynamics of humanized anti-CD25 Mab (Jiannipai) in a two-dose regimen in the first renal transplant recipients. Methods: Fifteen patients were enrolled and randomized to receive either Jiannipai (Jiannipai group, n=10) (IV. 1 mg·kg^-1) on operation day 0 and post-operation day 14. The serum levels of Jiannipai were measured by a directly competitive ELISA (EIA). Patients'lymphocyte subgroups of CD3⁺CD25⁺, CD4⁺, CD8⁺ were monitored periodically by flow cytometry. Results: Mean Jianipai Cmax ( X±SD()mg·L^-1) were 15.17±3.09, 17.77±5.74 on day 0, 14, and mean trough levels( X±SD)(mg·L^-1)were 2.21±1.30, 0.96±0.76 on day 14, 70, respectively. Elimination half-life of the antibody was 320 h with a total body clearance of 20.4 ml·h^-1. A significant decline of CD3- CD25⁺ and CD3⁺ CD25⁺ T-cells proportion (%) was observed after first daclizumab infusion 30 min on day 0, and these low levels remained stable for at least 70 days. Conclusion: The two-dose anti-CD25 Mab regimen is effective in rapidly achieving high therapeutic daclizumab's concentration in the treated patients and a significant decrease of CD3- CD25⁺ and CD3⁺CD25⁺ T lymphocytes for 70 days.