Healthy
Conditions
Keywords
Bioequivalence, Certolizumab pegol, Human Volunteers
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).
Interventions
DEVICEPrefilled syringe (PFS)
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
DEVICEe-Device
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device
Sponsors
Parexel
UCB BIOSCIENCES, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed