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 Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Device: Prefilled syringe (PFS)
* Device: e-Device


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Certolizumab Pegol injection by prefilled syringe<br> | Device: Prefilled syringe (PFS)<br>* Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)<br>|
| Experimental: Certolizumab Pegol injection by e-Device<br> | Device: e-Device<br>* Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Certolizumab pegol, Human Volunteers