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
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Certolizumab Pegol injection by prefilled syringe
|
Device: Prefilled syringe (PFS)
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
|
| Experimental: Certolizumab Pegol injection by e-Device
|
Device: e-Device
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device
|
Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) [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) [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)) [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 Outcome Measures
- Time of observed Cmax (tmax) [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) [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) [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) [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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is male or female and between 18 and 55 years of age at Screening.
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Subject is in good physical and mental health status determined on the basis of the medical history and a general clinical examination.
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Subject has no evidence of active or inactive Tuberculosis (TB).
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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:
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Subject receiving any live (includes attenuated) vaccination or immunoglobulins within 56 days preceding the CZP injection.
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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.).
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Subject is known to be intolerant to pegol.
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Subject has previously received CZP.
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Subject has received TNFα-inhibitors within 12 months or other biologic within 6 months before randomization into the study.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ra0132 001 | Baltimore | Maryland | United States |
Sponsors and Collaborators
- UCB BIOSCIENCES, Inc.
- Parexel
Investigators
- Study Director: UCB Cares, UCB Pharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RA0132