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)
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Keep this study
Lead
Genentech, Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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)
