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

NCT02806219 | Completed Phase 1 DMC

• 1 other identifier: RA0132
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Bioequivalence; Certolizumab pegol; Human Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

Study Arms (2)

Certolizumab Pegol injection by prefilled syringe

ACTIVE COMPARATOR

Device: Prefilled syringe (PFS)

Certolizumab Pegol injection by e-Device

EXPERIMENTAL

Device: e-Device

Interventions

Prefilled syringe (PFS) DEVICE

Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)

Certolizumab Pegol injection by prefilled syringe

e-Device DEVICE

Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device

Certolizumab Pegol injection by e-Device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB BIOSCIENCES, Inc.: lead
• Parexel: collaborator

Study Sites (1)

Ra0132 001

Baltimore, Maryland, United States

Location

Study Officials

• UCB Cares

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 20, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

US (1)