A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers

This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.

开始日期2019-11-13

申办/合作机构

嘉和生物药业有限公司

CTR20171510 / Active, not recruiting临床3期

比较GB221联合多西他赛和曲妥珠单抗联合多西他赛一线治疗HER2阳性的转移性乳腺癌患者的有效性、安全性的III期临床试验

比较GB221 联合多西他赛与曲妥珠单抗联合多西他赛两组的18 周客观缓解率（ORR）。

开始日期2018-05-09

申办/合作机构

嘉和生物药业有限公司

100 项与曲妥珠单抗生物类似药 (嘉和生物) 相关的临床结果

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100 项与曲妥珠单抗生物类似药 (嘉和生物) 相关的转化医学

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100 项与曲妥珠单抗生物类似药 (嘉和生物) 相关的专利（医药）

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项与曲妥珠单抗生物类似药 (嘉和生物) 相关的文献（医药）

2024-05-01·European Journal of Drug Metabolism and Pharmacokinetics

A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin®) in Healthy Chinese Adults

Article

作者: Song, Haifeng ; Wang, Xuan ; Zhu, Yu ; Fang, Yi ; Li, Xianbo ; He, Jin ; Xiao, Shuangshuang ; Liang, Xintong ; Hu, Zhiqin ; Zhan, Yaoxuan ; Wang, Xiaole ; Wang, Tenghua ; Ou, Lun ; Tian, Jingyuan ; Liu, Haiyan ; Li, Chen ; Chen, Liming ; Zheng, Qingshan ; Li, Tong ; Li, Yongmei

BACKGROUND AND OBJECTIVEGB221 is a recombinant humanized anti-HER2 monoclonal antibody. The purpose of this study was to evaluate the pharmacokinetic, safety, and immunogenicity of GB221 in healthy Chinese adults in comparison to trastuzumab (Herceptin^®).METHODSIn this randomized, double-blind, parallel-group phase I clinical trial, 88 subjects were randomized 1:1 to receive a single intravenous infusion (90-100 min) of GB221 or trastuzumab (6 mg/kg). The primary pharmacokinetic parameters-maximum observed serum concentration (C_max), area under the serum concentration-time curve from zero to the last quantifiable concentration at time t (AUC_0-t), and area under the serum concentration-time curve from time zero to infinity (AUC_0-∞)-of GB221 and trastuzumab were compared to establish whether the 90% confidence interval (CI) attained the 80-125% bioequivalence standard. Safety and immunogenicity were also evaluated.RESULTSThe GB221 group (n = 43) and the trastuzumab group (n = 44) showed similar pharmacokinetic characteristics. The geometric mean ratios (90% CI) of C_max, AUC_0-t, and AUC_0-∞ between the two groups were 107.53% (102.25-113.07%), 108.31% (103.57-113.26%), and 108.34% (103.57-113.33%), respectively. The incidence of treatment-emergent adverse events (TEAEs) was 83.7% (36/43) of the subjects in the GB221 group and 95.5% (42/44) of the subjects in the trastuzumab group. No subjects withdrew from the trial due to TEAEs, and there were no occurrences of serious adverse events. All subjects tested negative for antidrug antibodies (ADA).CONCLUSIONGB221 demonstrated similar pharmacokinetics to trastuzumab and comparable safety and immunogenicity in healthy Chinese adults.

100 项与曲妥珠单抗生物类似药 (嘉和生物) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB16380

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性乳腺癌	临床3期	中国	嘉和生物药业有限公司	2022-06-27
复发性乳腺癌	临床2期	中国	嘉和生物药业有限公司	2019-11-13
晚期 HER2 阳性乳腺癌	临床2期	中国	嘉和生物药业有限公司	2016-11-24