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

Sponsor
mAbxience Research S.L.
Study ID
NCT04238663
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 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
  • US licenced Avastin® — DRUG
    Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion

Study Details

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.

Key Dates

First listed
Jan 23, 2020
Start date
Sep 24, 2019
Status verified
Mar 2021
Primary completion
Mar 17, 2020
Completion
Mar 17, 2020

Study Design

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

Arms

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

Primary Outcome Measure

Cmax: Maximum Observed Serum Concentration [ Time Frame: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100. ]

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