Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Certolizumab pegol
Human Volunteers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2016-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 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.
measure: Area under the CZP plasma concentration-time curve from time 0 to infinity (AUC)
timeFrame: 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.
measure: Area under the CZP plasma concentration-time curve from time 0 to last observed quantifiable concentration (AUC(0-t))
timeFrame: 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:
measure: Time of observed Cmax (tmax)
timeFrame: 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.
measure: Terminal elimination half-life (t1/2)
timeFrame: 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.
measure: Apparent total body clearance (CL/F)
timeFrame: 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.
measure: Apparent volume of distribution (Vz/F)
timeFrame: 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.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Ra0132 001
state: Maryland
Study officials:
affiliation: UCB Pharma
name: UCB Cares
role: STUDY_DIRECTOR
References: