NCT02806219

Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects

Open-label, Single-center, Randomized, Parallel Group, Single-dose, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of a injection device (e-Device, test).

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Prefilled syringe (PFS)	Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
DEVICE	e-Device	Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-06-20
• Last updated: 2016-11-17

Locations

1 site across 1 country: United States