3 Formulations of Adalimumab (M923, EU & US Sourced Humira)
Research type
Research Study
Full title
A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Adalimumab (M923, US Sourced Humira and EU Sourced Humira) in Healthy Subjects
IRAS ID
164168
Contact name
Tim Mant
Contact email
Sponsor organisation
Baxter Innovations GmbH
Eudract number
2014-001043-20
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
This is a study to investigate and compare the pharmacokinetics(measuring drug levels in the blood over time), safety, tolerability and immunogenicity(blood tests to check the body's immune response to the drug) following single doses (40mg) of three different preparations of adalimumab given by ijection.
Adalimumab is a monoclonal antibody which is used to treat diseases such as rheumatoid arthritis and psoriasis. Adalimumab is marketed for use in the USA (US-Humira)and Europe (EU-Humira). The Sponsor (Baxter Innovations GmbH part of The Baxter Healthcare Corporation) is developing a monoclonal antibody M923 which is a similar biological medicinal product (biosimilar) to the marketed adalimumab preparations. M923 may have possible minor differences but is anticipated to have similar therapeutic effects.
M923 has not been given to humans before and in this study will be compared with the 2 marketed preparations of adalimumab. If the effects of M923 and the blood levels are very similar to the marketed preparations of adalimumab it is hoped that M923 will be an effective alternative.This study is being carried out on behalf of the Sponsor by Quintiles Ltd. It is a multisite study with three sites: Quintiles Ltd (London), Simbec(Wales) and Biokinetic Europe (Northern Ireland). 324 healthy male and female volunteer subjects are planned to participate. After reviewing the inclusion/exclusion criteria to ensure their safety, subjects will be randomly assigned to receive a single dose of one of the three above mentioned preparations. The study is double blind, so neither the subject or the investigators will know which preparation the individual volunteer receives at the time. The study will take place over approximately 9 months and involves a screening visit, a residential period where volunteers will be in-patients (eight nights), several outpatient visits and a final follow up visit.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/2007
Date of REC Opinion
11 Dec 2014
REC opinion
Further Information Favourable Opinion