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

NCT ID: NCT00813774

Last Updated: 2013-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bioavailability Study on Healthy Volunteers

Keywords

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Cimzia certolizumab pegol Bioavailability Healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Reference

Lyophilized formulation (reference)

Group Type ACTIVE_COMPARATOR

Certolizumab pegol

Intervention Type BIOLOGICAL

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

Liquid

Liquid Formulation (test)

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type BIOLOGICAL

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

Pre-filled Syringe

Pre-filled syringe (test)

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type BIOLOGICAL

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

Interventions

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Certolizumab pegol

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

Intervention Type BIOLOGICAL

Certolizumab pegol

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

Intervention Type BIOLOGICAL

Certolizumab pegol

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Cimzia CDP870 Cimzia CDP870 Cimzia CDP870

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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Rennes, , France

Site Status

Rueil-Malmaison, , France

Site Status

Countries

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France

Other Identifiers

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Eudract no. 2007-006344-22

Identifier Type: -

Identifier Source: secondary_id

RA0003

Identifier Type: -

Identifier Source: org_study_id