Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial,Expert Opinion on Biological Therapy

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Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial
Expert Opinion on Biological Therapy ( IF 4.6 ) Pub Date : 2021-07-26 , DOI: 10.1080/14712598.2021.1954157
Wenliang Dong _{1,

2} , Min Chen _{1,

2} , Suping Niu ₃ , Bianzhen Wang ₄ , Lin Xia _{1,

5} , Jiaxue Wang _{1,

2} , Tiantian Shen _{1,

5} , Qian Wang ₁ , Jie Lv ₆ , Gang Liu ₁ , Huaying Fan ₃ , Zhenwei Xie ₃ , Fan Xie ₇ , Youzhong An ₈ , Qingshan Zheng ₉ , Huiying Rao ₁₀ , Haifeng Song ₁₁ , Yi Fang ₁

Affiliation

Department of Pharmacy, Peking University People's Hospital, Beijing, China.
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical, Peking University, Beijing, China.
Department of Science and Research, Peking University People's Hospital, Beijing, China.
Beijing United-Power Pharma Tech Co.,Ltd, Beijing, China.
School of Pharmacy, Xuzhou Medical University, Xuzhou, China.
Department of Intensive Care Units, Peking University People's Hospital, Beijing, China.
Department of Clinical and Registration, Genor Biopharm Co., Ltd., Shanghai, China.
Department of Critical Care Medicine, Peking University People's Hospital, Beijing, China.
The Center for Drug Clinical Research of Shanghai University of TCM, Shanghai, China.
Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Disease, Beijing, China.
State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing), Beijing Institute of LifeOmics, Beijing, China.

ABSTRACT

Background

This study was conducted to compare the similarity of the pharmacokinetics (PKs), safety, and immunogenicity of GB222, a potential bevacizumab biosimilar, to that of reference bevacizumab in Chinese healthy males.

Research design and methods

This was a randomized, double-blind, single-dose, parallel-group clinical trial performed in 84 Chinese healthy males, who were randomly assigned to receive a single infusion dose of 1 mg/kg GB222 or bevacizumab with an 84-days follow-up. The primary endpoint was the area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration at time t (AUC_0-t). The second endpoints were the safety and immunogenicity evaluation. The PK bioequivalence was verified by the 90% confidence intervals (CIs) of the geometrical mean (GM) ratio for AUC_0-t falling within the bioequivalence margin, 80–125%.

Results

The PK profiles of GB222 and bevacizumab were comparable. The 90% CIs of GM ratio of GB222 to bevacizumab for AUC_0-t was within the pre-specified bioequivalence margin. The most common treatment-related adverse event was sinus bradycardia. Seventeen subjects (20.2%) tested positive for anti-drug antibodies (ADAs).