中国药业2018，Vol.27Issue(2)：6-10,5.DOI:10.3969/j.issn.1006-4931.2018.02.002
重组红细胞生成刺激蛋白单次皮下给药耐受性、安全性及药代动力学研究
Tolerance,Safety and Pharmacokinetic Characteristics of rESP with Single Subcutaneous Administration
摘要
Abstract
Objective To investigate the tolerance,safety,pharmacokinetic(PK) characteristics of rESP Injection (CHO cell) in healthy people administered by subcutaneous injections with single doses.Methods An open-lableand dosage accelerating method with single center was adopted.Healthy volunteers were enrolled into 7 groups (the dosage in the range of 0.10-3.00 μg/kg).The single dose was administered by the subcutaneous injection and subjects receiving the experimental drug were observed for 14 d.PK data were collected in 3 groups from the above 7 groups.Results Totally 38 subjects were enrolled in the 7 groups,and 36 cases completed the experiment.20 subjects suffered from 22 adverse events,18 of which were light pain at the injective site and considered related with rESP administration.Both of endogenous anti-EPO and anti-rESP antibodies in all subjects were negative except one who was reported positive of anti-rESP antibody during screening period and withdrawn from the study.3.00 μg/kg was finalized as the maximum-tolerated dose(MTD).rESP absorbing wasn′t impacted by the dosage in the range of 0.25-2.00 μg/kg.Process of absorbing and eliminating followed up linear PK characteristics.tpeak was 60 h.MRT was 195.97 h,and t1/2z was 120.7 h.Conclusion rESP has good tolerance and safety,and the process of absorbing and eliminating followed up linear PK characteristics with a long eliminating half time.关键词
重组红细胞生成刺激蛋白/健康受试者/耐受性/安全性/药代动力学Key words
rESP/healthy volunteer/tolerance/safety/pharmacokinetic分类
医药卫生引用本文复制引用
吴全睿,戎殳,梅长林,洪俊平,廖庆平..重组红细胞生成刺激蛋白单次皮下给药耐受性、安全性及药代动力学研究[J].中国药业,2018,27(2):6-10,5.基金项目
国家"十三五重大新药创制"科技重大专项[2016ZX09101113] （）
辽宁省沈阳市科技计划项目[F14-147-9-00]. （）
