Overview

This trial has been completed.

Condition healthy
Treatments prefilled syringe (pfs), e-device
Phase phase 1
Sponsor UCB BIOSCIENCES, Inc.
Collaborator Parexel
Start date March 2016
End date November 2016
Trial size 100 participants
Trial identifier NCT02806219, RA0132

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
prefilled syringe (pfs)
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
(Experimental)
e-device
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device

Primary Outcomes

Measure
Maximum observed plasma concentration (Cmax)
time frame: 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)
time frame: 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))
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.