Adalimumab biosimilar study in healthy volunteers
Research type
Research Study
Full title
A Phase I, Randomized, Double-Blind,Parallel-Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of MSB11022, US-Reference Product, and EU-Reference Medicinal Product (Humira®) in Healthy Subjects
IRAS ID
152298
Contact name
Timothy GK Mant
Contact email
Eudract number
2014-000662-21
ISRCTN Number
n/a
Research summary
This study is a single-dose trial to compare the pharmacokinetics (measuring drug levels in the blood over a period of time), safety, tolerability, and immunogenicity (blood tests to check the body’s immune response to the drug) of three different preparations of adalimumab. Adalimumab is a human antibody which binds to a specific target (tumour necrosis factor, TNFα) and is widely considered best-in-class for the treatment of several autoimmune diseases, including rheumatoid arthritis, psoriasis or inflammatory bowel diseases. Adalimumab has been marketed for use either in the USA (US-RP Humira®) or Europe (EU-RMP Humira®). The sponsor, Merck KGaA, Germany is developing a monoclonal antibody called MSB11022, which is a similar biologic drug (biosimilar) to marketed adalimumab that may have possible minor differences but anticipated to have similar therapeutic effects. MSB11022 is a new preparation that has not been used in humans before which will be compared with 2 marketed versions of adalimumab. If the effects of MSB11022 and the blood levels are very similar to the already marketed adalimumab, it is hoped MSB11022 will be an effective alternative. This study is being carried out on behalf of Merck KGaA by Quintiles. 213 healthy volunteers are planned to participate in this study, up to further 99 healthy volunteers might be enrolled depending on the outcome of the review after 50% of the volunteers have been included. After reviewing inclusion/exclusion criteria to ensure the safety of volunteers, volunteers will be randomly assigned to receive one of 3 abovementioned treatments. The study is double-blinded, so neither volunteers nor investigators will know which drug the individual volunteer receives at the time. The study will take place over approximately 10-15 weeks and involves a screening visit, one residential period where you will not be allowed to leave the unit; several out-patient visits and 1 follow-up visit.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/0562
Date of REC Opinion
22 May 2014
REC opinion
Further Information Favourable Opinion