NCT00813774

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

Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioavailability Study on Healthy Volunteers

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-12-23
• Last updated: 2013-09-09

Locations

2 sites across 1 country: France