Abstract

The objective of the study was to obtain information on the toxicity of biosimilar natalizumab (PB006) in comparison to the reference product Tysabri^®. Cynomolgus monkeys (15 males and 15 females), three animals per sex and group were treated with either PB006 or the reference product Tysabri^® at dose levels of 3 or 30 mg/kg body weight or placebo by intravenous infusion every other day for a period of 4 weeks. The study is also meant to facilitate ethics committee approval in specific countries for the planned confirmatory efficacy and safety study in patients. Based on study findings, it was concluded that there was no noteworthy difference between the animals treated with PB006 and the animals treated with Tysabri^®. There were no noteworthy differences between PB006 and Tysabri^® with respect to local tolerance, toxicity and pharmacokinetic profile in cynomolgus monkeys. In conclusion, obtained data are valid and suitable to support entry into clinical studies of PB006 in man.

摘要

该研究的目的是获得生物仿制药那他珠单抗 (PB006) 与参考产品 Tysabri ^®相比的毒性信息。食蟹猴（15 只雄性和 15 只雌性），每组每性别和每组 3 只动物接受 PB006 或参考产品 Tysabri® 治疗^，剂量水平为 3 或 30 mg/kg 体重或安慰剂，每隔一天静脉输注一段时间4 周。该研究还旨在促进特定国家的伦理委员会批准计划在患者中进行的验证性疗效和安全性研究。^{根据研究结果，得出的结论是，用 PB006 治疗的动物和用 Tysabri ®}治疗的动物之间没有显着差异. 在食蟹猴的局部耐受性、毒性和药代动力学特征方面， PB006 和 Tysabri ^®之间没有显着差异。总之，获得的数据是有效的，适合支持进入人体 PB006 的临床研究。