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

UCB Pharma149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

149

Conditions

Bioavailability Study on Healthy Volunteers

Interventions

Certolizumab pegolBIOLOGICAL

Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg

Certolizumab pegolBIOLOGICAL

Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg

Certolizumab pegolBIOLOGICAL

200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Rennes, France

Unnamed facility

Rueil-Malmaison, France