drugset
drugset / Trial / NCT04408989

A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®.

NCT04408989 ↗

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 PK, safety and immunogenicity profile of MB02-DM with MB02-SP and US-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
2021-01-11
Primary completion
2021-08-20
Completion
2021-09-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 1 mg/kg Intravenous
Subject MB02-DM Unknown 1 mg/kg Intravenous
Subject MB02-SP Unknown 1 mg/kg Intravenous

Indications

No indication recorded.