中国临床药理学杂志2011，Vol.27Issue(6)：439-442,4.
注射用鼠抗人T淋巴细胞CD25抗原单克隆抗体在健康受试者体内药代动力学与药效学
Pharmacokinetics and pharmacodynamics of monoclonal antibody of mouse antihuman T lymphocytes CD25 antigen in healthy Chinese volunteers
方凯 1黎维勇 1马林 1李茜 1乔建 1邓俊刚 1张爱华 2张囡 2孙可芳2
作者信息
- 1. 华中科技大学,同济医学院附属协和医院,武汉,430022
- 2. 武汉生物制品研究所,武汉430060
- 折叠
摘要
Abstract
Objective To study the pharmacokinetics and pharmacodynamics of monoclonal antibody of mouse anti - human T lymphocytes CD25 antigen (WuTac) in healthy Chinese subjects after single intravenous infusion. Methods The concentration of WuTac and human antimouse antibody (HAMA) in human plasma was determined to estimate the pharmacokinetic characteristics by the utilization of enzyme linked immunosorbent assay metnod(ELISA). The saturation of interleukin - 2 recepter (IL- 2R) on T lymphocyte was detected to evaluate the pharmacodynamic features using flow cytometer. Results The pharmacokinetic paramaters in three groups of high, middle, low dose levels are as follows: t1/2 were (54. 15 ± 16.50), (54.39 ± 21.17), (43.99 ±13.07) h; tmax were (2.50±2.02),(2.75 ±2.01),(2.08 ±2.06)h;Cmax were (2950. 82 ± 560. 94 ), ( 1461.20 ± 370. 70), ( 608. 95 ± 81.66)μg · L-1; AUC0-t were (8881.90 ± 2188. 10), (3711.00 ± 1146. 10),( 1158. 20 ± 306. 20) μg · L- 1 · d; AUC0- ∞ were ( 9458. 80 ± 2547. 80 ),(4115. 40 ± 1208. 40), ( 1269. 70 ± 310. 40) μg · L-1 · d, respectively.The saturation of IL -2R on T lymphocyte was more than 96％ 1 h after the infusion, and it maintained for more than 3 days. Conclusion WuTac exerted effect quickly, it was well tolerated , and showed linear pharmacokinetic characteritics.关键词
人抗鼠抗体/白介2受体/酶联免疫吸附/药代动力学/药效学Key words
human antimouse antibody/ interleukin- 2 recepter/ enzyme linked immunosorbent assay metnod/ pharmacokinetics/ pharmacodynamics分类
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方凯,黎维勇,马林,李茜,乔建,邓俊刚,张爱华,张囡,孙可芳..注射用鼠抗人T淋巴细胞CD25抗原单克隆抗体在健康受试者体内药代动力学与药效学[J].中国临床药理学杂志,2011,27(6):439-442,4.
