drugset
drugset / Trial / NCT03293654

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

NCT03293654 ↗

Phase 1 Completed 114 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
2017-12-07
Primary completion
2019-05-29
Completion
2019-05-29

Outcome

Mixed primary results

registry analysis (equivalence test); MB02 (Bevacizumab Biosimilar) vs US Licenced Avastin®; Ratio of GLSM 1.28 (90% CI 1.18 to 1.39) NCT03293654 ↗

registry analysis (equivalence test); MB02 (Bevacizumab Biosimilar) vs EU Approved Avastin®; Ratio of GLSM 1.16 (90% CI 1.09 to 1.22) NCT03293654 ↗

registry analysis (equivalence test); MB02 (Bevacizumab Biosimilar) vs US Licenced Avastin®; Ratio of GLSM 1.16 (90% CI 1.09 to 1.22) NCT03293654 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 3 mg/kg Intravenous
Subject MB02 Unknown 3 mg/kg Intravenous

Indications

No indication recorded.