Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

Phase 1 Completed 111 enrolled Mylan Inc.

RandomizedParallel-groupDouble-blindOther

Summary

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

Timeline

Start: 2015-04
Primary completion: 2015-10
Completion: 2015-10

Outcome

Met primary endpoint

paper Bioequivalence was demonstrated between MYL-1402O and EU-reference bevacizumab, MYL-1402O and US-reference bevacizumab, and between EU- and US-reference bevacizumab PMID 33866430 ↗

paper 90% CIs were within the equivalence range (0.80-1.25). PMID 33866430 ↗

Publications

Hummel M, Bosje T, Shaw A, Liu MS, Barve A, Kothekar M, Socinski MA, Waller CF. A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab. J Cancer Res Clin Oncol. 2022 Feb;148(2):487-496. doi: 10.1007/s00432-021-03628-0. Epub 2021 Apr 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	MYL-1402O	Monoclonal antibody	1 mg/kg	Intravenous

Indications

No indication recorded.