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

Sponsor
mAbxience Research S.L.
Study ID
NCT04238650
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers
  • Japanese
  • Male

Eligibility Criteria

Sex
MALE
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • MB02 (Bevacizumab Biosimilar) — DRUG
    Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion
  • EU approved Avastin® — DRUG
    Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion

Study Details

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.

Key Dates

First listed
Jan 23, 2020
Start date
Aug 2, 2019
Status verified
Feb 2021
Primary completion
Dec 27, 2019
Completion
Dec 27, 2019

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: MB02 (Bevacizumab Biosimilar)
    Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.
  • Active Comparator: EU approved Avastin®
    Intervention Description: Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1.

Primary Outcome Measure

Area Under the Serum Concentration-time Curve From Time Zero to Infinity [AUC(0-∞)] [ Time Frame: Predose, end of infusion, 2, 3, 4, 5, 6, 8, 12, 24 h post-dose on Day 1-8, Day 10, Day 14, Day 21, Day 28, Day 38, Day 50, Day 62, and Day 70. ]

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