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

UCB logo

UCB

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Device: Prefilled syringe (PFS)
Device: e-Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02806219
RA0132

Details and patient eligibility

About

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).

Enrollment

100 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Certolizumab Pegol injection by prefilled syringe
Active Comparator group
Treatment:
Device: Prefilled syringe (PFS)
Certolizumab Pegol injection by e-Device
Experimental group
Treatment:
Device: e-Device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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