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European Journal of Drug Metabolism and Pharmacokinetics

Erschienen in:

02.04.2024 | Original Research Article

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

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

Erschienen in: European Journal of Drug Metabolism and Pharmacokinetics | Ausgabe 3/2024

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Abstract

Background and Objective

GB221 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^®).

Methods

In 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.

Results

The 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).

Conclusion

GB221 demonstrated similar pharmacokinetics to trastuzumab and comparable safety and immunogenicity in healthy Chinese adults.

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Titel: A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin®) in Healthy Chinese Adults
verfasst von: Yu Zhu
Chen Li
Liming Chen
Haiyan Liu
Lun Ou
Tong Li
Xuan Wang
Tenghua Wang
Jingyuan Tian
Xintong Liang
Zhiqin Hu
Yaoxuan Zhan
Shuangshuang Xiao
Xiaole Wang
Yongmei Li
Jin He
Qingshan Zheng
Haifeng Song
Xianbo Li
Yi Fang
Publikationsdatum: 02.04.2024
Verlag: Springer International Publishing
Erschienen in: European Journal of Drug Metabolism and Pharmacokinetics / Ausgabe 3/2024
Print ISSN: 0378-7966
Elektronische ISSN: 2107-0180
DOI: https://doi.org/10.1007/s13318-024-00889-1

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

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

Abstract

Background and Objective

Methods

Results

Conclusion

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

Abstract

Background and Objective

Methods

Results

Conclusion

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