Quantitative Analysis of KH903 from Human Serum by Enzyme-Linked Immunosorbent Assay and its Application in a Pharmacokinetic Study

Authors: Bing Tian Bi, Ben Y. Zou, Min J. Zhao, Wen L. Zhu, Xiao Ke, Li T. Deng, Hai Liao, Jing Zhan, Kun Y. Feng, Su Li

KH903 is a novel antiangiogenic drug for cancer therapy. Its pharmacokinetic study in cancer patients is therefore very important for choosing doses and dosing intervals in clinical application. A selective, sensitive, and rapid Enzyme-Linked Immunosorbent Assay (ELISA) method was developed and validated here for the determination of KH903 in patient serum. This method is specific enough for the detection of KH903 in serum samples. Nonlinear calibration curves were obtained for KH903 at a concentration range of 0.781-50 ng/ ml (r > 0.999). The intra-batch accuracy ranged from 83.4% to 94.5%, and the inter-batch accuracy varied from 88.8% to 91.7%. Stability tests showed that KH903 was stable throughout the analytical procedure. This study is the first to utilize the ELISA method for the pharmacokinetic study of KH903 in six cancer patients who had received a single dose of KH903 (4.0 mg/ kg) administered intravenously. The results address the pharmacokinetic profile of KH903 in cancer patients in detail and evaluate the binding efficacy of KH903 on VEGF in patients to provide guidance for the regimen of KH903 in phase I clinical trials. You can submit your Manuscripts at: 

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[v1] 2017-08-28 02:24:17

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