Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects

Summary

The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.

Timeline

Start

2016-03-15

Primary completion

2017-05-16

Completion

2017-06-28

Outcome

Met primary endpoint

paper The 90% CI for the AUC0-inf was 99-112% for BAT1706 versus EU-BEV PMID 31016568 ↗

paper BAT1706, a proposed biosimilar of BEV, was shown to be highly similar to EU-BEV and US-BEV in terms of pharmacokinetic equivalence PMID 31016568 ↗

Publications

• Wu X, Wynne C, Xu C, Gan Y, Wang C, Thomas BE, Yu JC, Li S, Zhang L. A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin(R)) in Healthy Male Subjects. BioDrugs. 2019 Jun;33(3):335-342. doi: 10.1007/s40259-019-00352-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BAT1706	Unknown	1 mg/kg	Intravenous
Comparator	Bevacizumab	Monoclonal antibody	1 mg/kg	Intravenous

Indications