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

NCT04408989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MB02-SP

Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

DRUG

MB02-DM

Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

DRUG

US licenced Avastin®

Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Principal Investigators

  • Christian Schwabe, MD · Auckland Clinical Studies

  • Alexandra Cole, MD · Christchurch Clinical Studies

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
2021-01-11
Primary Completion
2021-08-20
Completion
2021-09-02

Countries

  • New Zealand

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 NCT04408989 on ClinicalTrials.gov