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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Pharma
• Treatments: Certolizumab Pegol

Criteria

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