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
NCT ID: NCT02806219
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
100 participants
INTERVENTIONAL
2016-03-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Certolizumab Pegol injection by prefilled syringe
Prefilled syringe (PFS)
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
Certolizumab Pegol injection by e-Device
e-Device
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device
Interventions
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Prefilled syringe (PFS)
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
e-Device
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Parexel
INDUSTRY
UCB BIOSCIENCES, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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Ra0132 001
Baltimore, Maryland, United States
Countries
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Other Identifiers
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RA0132
Identifier Type: -
Identifier Source: org_study_id