drugset / Trial / NCT04238663

Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

Phase 1 Completed 115 enrolled mAbxience Research S.L.

RandomizedParallel-groupTriple-blindOther

Summary

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Timeline

Start: 2019-09-24
Primary completion: 2020-03-17
Completion: 2020-03-17

Outcome

Met primary endpoint

registry if the 90% confidence interval (CI) for the geometric LS means ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25. NCT04238663 ↗

registry analysis (equivalence test); MB02 (Bevacizumab Biosimilar) vs EU Approved Avastin®; Ratio of Geometric Least Square Mean 1.06 (90% CI 0.976 to 1.16) NCT04238663 ↗

registry analysis (equivalence test); MB02 (Bevacizumab Biosimilar) vs US Licenced Avastin®; Ratio of Geometric Least Square Mean 0.983 (90% CI 0.897 to 1.08) NCT04238663 ↗

registry analysis (equivalence test); EU Approved Avastin® vs US Licenced Avastin®; Ratio of Geometric Least Square Mean 0.926 (90% CI 0.851 to 1.01) NCT04238663 ↗

registry analysis (equivalence test); MB02 (Bevacizumab Biosimilar) vs EU Approved Avastin®; Ratio of GLSM 1.07 (90% CI 1.00 to 1.14) NCT04238663 ↗

registry analysis (equivalence test); MB02 (Bevacizumab Biosimilar) vs US Licenced Avastin®; Ratio of GLSM 0.998 (90% CI 0.944 to 1.05) NCT04238663 ↗

registry analysis (equivalence test); EU Approved Avastin® vs US Licenced Avastin®; Ratio of GLSM 0.934 (90% CI 0.884 to 0.988) NCT04238663 ↗

Publications

Sinn A, Garcia-Alvarado F, Gonzalez V, Huerga C, Bullo F. A randomized, double blind, single dose, comparative study of the pharmacokinetics, safety and immunogenicity of MB02 (bevacizumab biosimilar) and reference bevacizumab in healthy male volunteers. Br J Clin Pharmacol. 2022 Mar;88(3):1063-1073. doi: 10.1111/bcp.15032. Epub 2021 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	MB02	Unknown	3 mg/kg	Intravenous

Indications

No indication recorded.