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

UCB

Status and phase: Completed; Phase 1

Conditions: Bioavailability Study on Healthy Volunteers

Treatments: Biological: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813774

RA0003

Eudract no. 2007-006344-22

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 3 patient groups

Reference

Active Comparator group

Description:

Lyophilized formulation (reference)

Treatment:

Biological: Certolizumab pegol

Biological: Certolizumab pegol

Biological: Certolizumab pegol

Liquid

Experimental group

Description:

Liquid Formulation (test)

Treatment:

Biological: Certolizumab pegol

Biological: Certolizumab pegol

Biological: Certolizumab pegol

Pre-filled Syringe

Experimental group

Description:

Pre-filled syringe (test)

Treatment:

Biological: Certolizumab pegol

Biological: Certolizumab pegol

Biological: Certolizumab pegol