MedTrace Logo

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

NCT04238663 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-10-25

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MB02 (Bevacizumab Biosimilar)

Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion

DRUG

EU approved Avastin®

Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion

DRUG

US licenced Avastin®

Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Principal Investigators

  • Angela Sinn, MD · Early Phase Clinical Unit (EPCU) PAREXEL International GmbH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2020-03-17
Completion
2020-03-17
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238663 on ClinicalTrials.gov