Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers

Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers

To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.

Inclusion Criteria:

• Healthy male and female volunteers aged between 18 and 55
• Body Mass Index (BMI) between 18 and 30 kg/m2 with normal laboratory data
• negative for Tuberculosis test
• normal Electrocardiogram (ECG)
• adequate contraception for females
• given informed consent

Exclusion Criteria:

• Any significant abnormality in medical history, physical examination, laboratory testing
• Intake of concomitant medication
• smoking more than 10 cigarettes per day
• alcohol or drug abuse
• pregnancy or breast feeding
• history of tuberculosis
• participation in another trial within 3 months prior to this study
• previous administration of certolizumab pegol