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
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Device: Prefilled syringe (PFS)Device: e-Device
- Registration Number
- NCT02806219
- Lead Sponsor
- UCB BIOSCIENCES, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Certolizumab Pegol injection by prefilled syringe Prefilled syringe (PFS) - Certolizumab Pegol injection by e-Device e-Device -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Ra0132 001
🇺🇸Baltimore, Maryland, United States