IBI305和安维汀临床前安全性相似性评价

发布时间：2019-03-09 13:20

【摘要】：目的:比较IBI305和安维汀的临床前安全性。方法:将50只食蟹猴随机分为溶媒对照组、IBI305低剂量组、中剂量组、高剂量组和安维汀组,每组10只,雌雄各半。每周静脉推注给药2次,共给药9次。观察动物的临床症状,测定动物的体重、摄食量、体温、血液学和血液生化、眼科学、尿液以及血清抗体的变化情况,并检测心电图、血压等安全药理学指标,进行毒代动力学研究。比较2个药物引起的大体病理学和组织病理学变化。结果:二者均可引起动物皮肤发红,均可引起膝关节和脾脏的病变。在同等剂量下,二者的主要毒代动力学参数相似。IBI305和安维汀均可以引起抗药抗体产生。结论:同等剂量下,IBI305和安维汀毒性反应、毒代动力学特点和免疫原性均相似。
[Abstract]:Objective: to compare the preclinical safety of IBI305 and Avirin. Methods: 50 crab-eating monkeys were randomly divided into three groups: solvent control group, low-dose IBI305 group, middle-dose group, high-dose group and amberine group (n = 10, male and female, n = 10). Intravenous infusion 2 times a week, a total of 9 times. The changes of clinical symptoms, body weight, intake, body temperature, hematology and blood biochemistry, ophthalmology, urine and serum antibodies, as well as safety pharmacological indexes such as electrocardiogram and blood pressure, were observed, and the body weight, food intake, body temperature, hematology and biochemistry, ophthalmology, urine and serum antibodies were measured. The toxicokinetics was studied. The changes of gross pathology and histopathology induced by two drugs were compared. Results: both of them could cause redness of animal skin and pathological changes of knee joint and spleen. At the same dose, the main toxicokinetic parameters of the two groups were similar. Both IBI 305 and Avirin could induce the production of anti-drug antibodies. Conclusion: at the same dose, the toxicity, pharmacokinetics and immunogenicity of IBI305 and Avirin were similar.
【作者单位】：中国食品药品检定研究院;信达生物制药(苏州)有限公司;
【基金】：国家“重大新药创制”科技重大专项(2012ZX09302001)
【分类号】：R965

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