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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB BIOSCIENCES, Inc.
With
Parexel
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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.
Clareo Health | 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
