A Double-Blind, Biosimilar Study of MB02 in Healthy Males
Research type
Research Study
Full title
A Randomised, Double-Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar Drug), US-licenced Avastin® and EU-approved Avastin® in Healthy Male Volunteers
IRAS ID
230705
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
mAbxience Research S.L.
Eudract number
2017-003004-40
Duration of Study in the UK
0 years, 6 months, 11 days
Research summary
MB02 is an investigational medicinal product similar to the drug Avastin; which is used in different cancer treatments. Avastin acts by inhibiting the formation of new blood vessels leading to decreased tumour growth and progression. Avastin is currently marketed in the EU and the US.
The main aims of this study are to compare the absorption, blood concentrations after administration and safety of MB02 to the EU and US marketed Avastin. The study also investigates the potential for antibody (molecules produced in body against a drug) development against these three compounds.
Volunteers will be admitted to the Clinical Research Unit (CRU) on Day 1 (day before drug administration), and will be confined to the CRU until discharge on Day 8. On Day 1, subjects will receive a single 3 mg/kg IV dose of the study drug. Subjects will return on Days 10, 14, 21, 28, 42, 56, 63 and 70 for non-residential visits for the collection of blood samples to test drug concentration and safety laboratory tests.
A total of 99 subjects (volunteers) will be assigned to one of following 3 arms in a 1:1:1 ratio:
• Arm 1: MB02 as a 90 minute IV (through a blood vessel) infusion
• Arm 2: Avastin® sourced from the US, as a 90 minute IV infusion
• Arm 3: Avastin® sourced from the EU, as a 90 minute IV infusion.
Thirty-three subjects will be dosed in each arm. Potential subjects will be screened to assess their eligibility to enter the trial within 30 days prior to study drug administration.REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1176
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion