A randomized phase I clinical trial comparing the pharmacokinetic, safety, and immunogenicity of potential biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab in healthy Chinese adults.

Jiaxue Wang,Suping Niu,Wenliang Dong,Li Wei,Lun Ou,Tan Zhang,Liangbi Zhang,Xiaoyan Nie,Qian Wang,Tiantian Shen,Qi Wang,Lin Xia,Gang Liu,Jiting Jin,Qingshan Zheng,Haifeng Song,Yi Fang

A randomized phase I clinical trial comparing the pharmacokinetic, safety, and immunogenicity of potential biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab in healthy Chinese adults.

2020

Jiaxue Wang
Suping Niu
Wenliang Dong
Li Wei
Lun Ou
Tan Zhang
Liangbi Zhang
Xiaoyan Nie
Qian Wang
Tiantian Shen
Qi Wang
Lin Xia
Gang Liu
Jiting Jin
Qingshan Zheng
Haifeng Song
Yi Fang

Recombinant human HER2 monoclonal antibody for injection (AK-HER2) is a potential biosimilar of trastuzumab (Herceptin®). This phase Ⅰ study aimed to demonstrate the pharmacokinetic (PK) equivalenc...

Keywords:

Pharmacology
Trastuzumab
Medicine
Recombinant DNA
Immunogenicity
Biosimilar
Phases of clinical research
Pharmacokinetics
chinese adults
HER2 Monoclonal Antibody

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