Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)

Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.

To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).

Inclusion Criteria:

• Age: 18-55 years.
• A Body mass Index (BMI) of 18 to 28 kg/m
• Good physical and mental health status determined on the basis of the medical history and a general clinical examination
• Electrocardiogram and clinical laboratory tests interpreted as "normal"
• QuantiFERON-TB test negative
• female subjects: medically accepted method of contraception

Exclusion Criteria:

• prohibited concomitant medication
• administered vaccines and immunoglobulins in the month preceding the certolizumab pegol injection
• history of significant disease, allergies
• history of drug and/or alcohol abuse
• hepatic enzyme inducing drug within 2 months before study drug administration
• any drugs having influence of the immune response and antibiotic in the month preceding the inclusion
• known to be intolerant to PEG
• previously received certolizumab pegol
• previously received an antibody product within 5-half lives of the antibody or within 3 months of the start of the study
• history of tuberculosis
• have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or Hepatitis C antibody or who is HIV positive