Effects of recombinant fusion protein of human tumor necrosis factor receptor mutant and Fc fragment for injection on the plasma concentration of tumor necrosis factor-α in Chinese healthy volunteers
10.13699/j.cnki.1001-6821.2018.03.037
- VernacularTitle:注射用重组人肿瘤坏死因子受体突变体-Fc融合蛋白对中国健康志愿者血浆中肿瘤坏死因子-α浓度水平的影响
- Author:
Yi-Tong WANG
1
;
Yan LI
;
Chang LIU
;
Wei WANG
;
Qian WANG
;
Li-Hou DONG
;
Shi CHEN
;
Yan-Nan ZANG
;
Zhen-Wei XIE
;
Zhan-Guo LI
;
Hai-Feng SONG
;
Yi FANG
Author Information
1. 北京大学人民医院药剂科
- Keywords:
recombinant fusion protein of human tumor necrosis factor receptor mutant and Fc fragment;
tumor necrosis factor-α;
etanercept
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(3):312-315,326
- CountryChina
- Language:Chinese
-
Abstract:
Objective To access the effects of different doses of recombinant fusion protein of human tumor necrosis factor receptor mutant and Fc fragment [rhTNFR(m):Fc] after a single subcutaneous injection on the plasma concentration of tumor necrosis factor-α (TNF-or) in Chinese healthy volunteers.Methods A total of 56 healthy Chinese volunteers were randomly divided into 6 groups to receive a single injection of 10,20,35,65,75 mg of rhTNFR(m):Fc.The plasma concentrations of TNF-α and total TNF-α were determined at 1 h pre-dose and at 4,48,96,168,216,264,312,384,480 h post-dose.Results After administration of rhTNFR(m):Fc at 0-264 h,the plasma concentrations of free TNF-α and total TNF-α increased significantly in the each group.At 264-480 h post-dose,the concentration of them began to decrease,and at 480 h the concentration of free TNF-α almostly decreased to normal levels.In the dose range of 10-75 mg,the exposure of free TNF-α and total TNF-α (Cmax) had no significant correlation with the dose of rhTNFR (m):Fc.Conclusion After giving the single dose of rhTNFR (m):Fc,there was an increase of free and total TNF-α plasma concentration in Chinese healthy volunteers.As a result,the plasma concentration of free and total TNF-α may not be a suitable pharmacodynamic evaluation index.
