Anti-drug antibodies of tumor necrosis factor alpha monoclonal antibody injection in Chinese healthy adult volunteers and analysis its influence factors
10.13699/j.cnki.1001-6821.2017.09.006
- VernacularTitle:肿瘤坏死因子-α单克隆抗体注射剂在中国健康成年志愿者中抗药抗体产生及其影响因素分析
- Author:
Bing-Feng XU
1
;
Yi-Tong WANG
;
Chang LIU
;
Qian WANG
;
Xin-Yao XIE
;
Hai-Feng SONG
;
Yi FANG
Author Information
1. 徐州医科大学药学院
- Keywords:
tumor necrosis factor alpha monoclonal antibody;
Chinese healthy adult volunteer;
anti-drug antibody
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(9):790-793
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the ratio of anti-drug antibody(ADA) produced by tumor necrosis factor alpha (TNF-α) monoclonal antibody in Chinese healthy adult volunteers,and to analyze its influencing factors.Methods This is a parallel,randomized,double-blind,controlled study.Three sets of test totally included 164 cases of Chinese healthy adult volunteers.Trial one:56 cases of Chinese healthy adult volunteers were randomized into six groups,given 10,20,35,50,65,75 mg of L00653 test drugs in abdominal subcutaneous injection way.Trial two:64 cases of Chinese healthy adult volunteers were divided into six groups,given 5,15,30,50,75,100 mg of the test drug L02151 by abdominal subcutaneous injection.Trial three:48 cases of Chinese healthy adult volunteers were randomized into four groups,The volunteers in each group were given L00)048 and primary research drugs by intravenous infusion according to 1∶1 proportion as controlled trials.The levels of ADA were measured by ligand binding assay (LBA).Results A total of 164 healthy volunteers were performed in the study.Trail one:The positive rates of A,B,C,D,E,F groups were 17.00％,20.00％,40.00％,30.00％,0,30.00％,respectively.There was no significant difference between ADA positive rate and administration dose (P ＞ 0.05);Trail two:The positive rates of 5,15,30,50,75 and 100 mg groups were 100.00％,1000.00％,100.00％,100.00％,100.00％,70.00％,respectively.There was no significant difference in ADA positive rate between the groups and the dose of Administration (P ＞ 0.05);Trail three:Only two cases of ADA appeared.Conclusion The ADA produced in the body by TNF-o monoclonal antibody drug was associated with its source and structure,but without close relationship with drug doses.The research could be used to TNF-o monoclonal antibody drug research,providing experimental basis for clinical safe use.
