CompletedNCT02806219Updated Nov 17, 2016

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

A Phase 1 interventional study of Prefilled syringe (PFS) and e-Device in Healthy, sponsored by UCB BIOSCIENCES, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-17.

Sponsored by UCB BIOSCIENCES, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 studied

Healthy

Keywords

Bioequivalence
Certolizumab pegol
Human Volunteers

In context

Lead sponsor

UCB BIOSCIENCES, Inc. is the lead sponsor of 28 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subject is male or female and between 18 and 55 years of age at Screening.
Subject is in good physical and mental health status determined on the basis of the medical history and a general clinical examination.
Subject has no evidence of active or inactive Tuberculosis (TB).
Female subjects of childbearing potential should have a negative pregnancy test at study entry and should be using a medically accepted method of contraception during the entire duration of the study and for 10 weeks after the final dose of CZP.

Female subjects who are postmenopausal for at least 2 years and have a serum follicle stimulating hormone (FSH) level >40mIU/mL at the Screening Visit, or have undergone a hysterectomy, bilateral tubal ligation, and/or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential.

Exclusion criteria

Exclusion Criteria:

Subject receiving any live (includes attenuated) vaccination or immunoglobulins within 56 days preceding the CZP injection.
Subject has taken any drugs (including over-the-counter medications) within 56 days preceding the CZP injection (with the exception of those noted in Section 7.8.1.).
Subject is known to be intolerant to pegol.
Subject has previously received CZP.
Subject has received TNFα-inhibitors within 12 months or other biologic within 6 months before randomization into the study.
Subject has an active or chronic/latent infection including TB, hepatitis C virus (HCV), hepatitis B core antigen (HBc), or human immunodeficiency virus (HIV).-- Subject has symptomatic herpes zoster infection (shingles) within 6 months prior to Screening.
Subject has chronic, serious, opportunistic recurring infection or condition within 6 months prior to Screening.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (actual)

Study arms

Active comparator
Certolizumab Pegol injection by prefilled syringe
Device: Prefilled syringe (PFS)
Experimental
Certolizumab Pegol injection by e-Device
Device: e-Device

Interventions

DevicePrefilled syringe (PFS)
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
Devicee-Device
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device

What researchers measure

Primary outcomes

Maximum observed plasma concentration (Cmax)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to infinity (AUC)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to last observed quantifiable concentration (AUC(0-t))
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.

Secondary outcomes

Time of observed Cmax (tmax)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Terminal elimination half-life (t1/2)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Apparent total body clearance (CL/F)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Apparent volume of distribution (Vz/F)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.

Study locations

1 site

Ra0132 001
Baltimore, Maryland, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02806219
Lead sponsor: UCB BIOSCIENCES, Inc.
Collaborators: Parexel
Responsible party: Sponsor
First posted: Jun 20, 2016
Start date: Mar 2016
Primary completion: Nov 2016
Completion: Nov 2016
Last update: Nov 17, 2016

Study contacts

UCB Cares

study director · UCB Pharma

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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