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

NCT04238650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-03-23

Study results available
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Summary

A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers.

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
  • Male
  • Japanese

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

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Principal Investigators

  • Takashi ETO, MD · SOUSEIKAI Hakata Clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-02
Primary Completion
2019-12-27
Completion
2019-12-27

Countries

  • Japan

Study Locations

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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 NCT04238650 on ClinicalTrials.gov