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Clinical Trials associated with Rituximab biosimilar(Shenzhen Main Luck Pharmaceuticals, Inc.)评价WLB -302与美罗华在非霍奇金淋巴瘤患者中药代动力学 、免疫原性、安全性的随机、双盲的临床研究
[Translation] A randomized, double-blind clinical study to evaluate the pharmacokinetics, immunogenicity, and safety of WLB-302 and rituximab in patients with non-Hodgkin's lymphoma
主要: 评价单次给药后重组人鼠嵌合抗CD20单克隆抗体注射液(WLB-302)与美罗华®主要药代动力学参数 AUC (0 - t) 的相似性 ; 次要: 1.给药后WLB-302与美罗华 ®AUC0-∞及 Cmax 的相似性; 2.给药后WLB-302与美罗华 ®在非霍奇金淋巴瘤患者中CD19、CD20阳性B细胞计数变化; 3.给药后WLB-302与美罗华 ®在非霍奇金淋巴瘤患者中不良事件发生率的差异,ADA、实验室、生命体征、心电监测、心电图、体格检查的变化 。
[Translation] Primary: To evaluate the similarity of the main pharmacokinetic parameter AUC (0 - t) between recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection (WLB-302) and Rituxima® after a single dose; Secondary: 1. The similarity of AUC0-∞ and Cmax between WLB-302 and Rituxima® after administration; 2. The changes in CD19 and CD20 positive B cell counts between WLB-302 and Rituxima® in patients with non-Hodgkin's lymphoma after administration; 3. The differences in the incidence of adverse events between WLB-302 and Rituxima® in patients with non-Hodgkin's lymphoma after administration, and the changes in ADA, laboratory, vital signs, ECG monitoring, electrocardiogram, and physical examination.
100 Clinical Results associated with Rituximab biosimilar(Shenzhen Main Luck Pharmaceuticals, Inc.)
100 Translational Medicine associated with Rituximab biosimilar(Shenzhen Main Luck Pharmaceuticals, Inc.)
100 Patents (Medical) associated with Rituximab biosimilar(Shenzhen Main Luck Pharmaceuticals, Inc.)
100 Deals associated with Rituximab biosimilar(Shenzhen Main Luck Pharmaceuticals, Inc.)