Status:
COMPLETED
Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers
Lead Sponsor:
UCB Pharma
Conditions:
Bioavailability Study on Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00813774
Start Date
February 1 2008
End Date
July 1 2008
Last Update
September 9 2013
Active Locations (2)
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1
Rennes, France
2
Rueil-Malmaison, France