A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Within the body weight range of 60 to 100 kilograms, inclusive (for the pivotal cohort [Part 2] only)
- Within body mass index (BMI) range 18.0 to 30.0 kilograms per square meter (kg/m^2), inclusive
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs
- Females will be non-pregnant, non-lactating, and either postmenopausal (at least 12 months of non-therapy-induced amenorrhea)/surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days prior to enrolment, or agree to remain abstinent/use a highly effective method of contraception for at least 24 weeks after study drug administration
- Males will either be sterile or agree to remain abstinent/use a highly effective method of contraception for at least 24 weeks after study drug administration. Male participants will refrain from sperm donation from Check-in (Day -1) until 24 weeks following study drug administration
Exclusion criteria
- Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
- Any prior treatment with anti-mucosal addressin cell adhesion molecule 1 (anti-MAdCAM-1) agents
- Any prior treatment with rituximab
- Received intravenous corticosteroids within 30 days prior to Screening
- Use of agents that deplete B or T cells (e.g., alemtuzumab, rituximab, or visilizumab) within 12 months prior to randomization
- Any prior immunosuppressive agents (including cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil)
- Chronic nonsteroidal anti-inflammatory drug (NSAID) use
- Use of any prescription medications/products within 14 days prior to Check in (Day -1)
- History of demyelinating disease
- Neurological conditions or diseases
- History of cancer
- History of alcoholism or drug addiction within less than (<) 1 year prior to Screening
- History of active or latent tuberculosis (TB), regardless of treatment history
- History of recurrent opportunistic infections and/or history of severe disseminated viral infections
- Positive for human immunodeficiency virus (HIV) antibody
- Any current or recent signs or symptoms of infection
- Pregnant or lactating
- Hospitalized within 4 weeks prior to and during Screening
- History of organ transplant
- Presence of skin rash at Screening or history of other skin disorders
- Tattoos, scars, chronic rashes, or sunburn in the area of the designated injection site
Trial design
Primary purpose
Allocation
Interventional model
Masking
180 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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