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
- Resource Type
- Article
- Authors
- Wang, Jiaxue; Niu, Suping; Dong, Wenliang; Wei, Li; Ou, Lun; Zhang, Tan; Zhang, Liangbi; Nie, Xiaoyan; Wang, Qian; Shen, Tiantian; Wang, Qi; Xia, Lin; Liu, Gang; Jin, Jiting; Zheng, Qingshan; Song, Haifeng; Fang, Yi
- Source
- Expert Opinion on Investigational Drugs; July 2020, Vol. 29 Issue: 7 p755-762, 8p
- Subject
- Language
- ISSN
- 13543784; 17447658
ABSTRACTObjectivesRecombinant 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) equivalence between AK-HER2 and trastuzumab in healthy volunteers. Besides, safety and immunogenicity were investigated.Research design and methodsThis was a randomized, double-blind phase Ⅰ trial in 96 healthy adults who received a single intravenous infusion of AK-HER2 or trastuzumab at 6 mg/kg. The primary PK endpoints were area under the serum concentration curve (AUC) from time 0 to the last time point (AUC0-t) and peak concentration in serum (Cmax). The PK bioequivalence was confirmed using the standard equivalence margins of 80%-125%.ResultsThe PK profiles of AK-HER2 and trastuzumab displayed high similarity. The geometric mean ratios (90% confidence intervals) of primary PK endpoints were within 80%-125%. The C max and AUC 0-t of female subjects in the AK-HER2 group were greater than those of male subjects (P <0.05). No infusion-related reactions (IRRs) or anti-drug antibody-positivity was observed after dosing.ConclusionsAK-HER2 was demonstrated to have highly similar PK to trastuzumab in healthy Chinese adults. Both drugs showed comparable safety and immunogenicity using dexamethasone as premedication to prevent IRRs..