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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00813774 |
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.
Condition | Intervention | Phase |
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Bioavailability Study on Healthy Volunteers |
Biological: Certolizumab pegol |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Parallel Assignment, Bio-availability Study |
Official Title: | Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers |
Enrollment: | 149 |
Study Start Date: | February 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Reference: Active Comparator
Lyophilized formulation (reference)
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Biological: 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
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Liquid: Experimental
Liquid Formulation (test)
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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
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Pre-filled Syringe: Experimental
Pre-filled syringe (test)
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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
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | RA0003, Eudract no. 2007-006344-22 |
Study First Received: | December 19, 2008 |
Last Updated: | July 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00813774 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Cimzia certolizumab pegol Bioavailability Healthy volunteers |
Immunoglobulin Fab Fragments Antibodies Immunologic Factors Healthy Immunoglobulins |
Immunoglobulin Fab Fragments Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |