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

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Certolizumab pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00845663

C87045

Details and patient eligibility

About

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).

Enrollment

98 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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