Pharmacokinetic Comparability of Benralizumab using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers

Exclusion Criteria

• - History of any clinically significant disease, severe allergy/anaphylaxis to any biologic therapy, Guillain-Barré syndrome, smoking and alcohol or drug abuse
• - Diagnosis of helminth parasitic infection and acute upper or lower respiratory infections
• - Disorders related to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment
• - Alanine aminotransferase/aspartate aminotransferase level ≥1.5 times the upper limit of normal
• - White blood cell count and neutrophils < lower limit of normal
• - Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP)
• - Positive result for serum hepatitis B surface antigen or anti-Hemoglobin C (anti-HBc) antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
• - Intake of new chemical entity (not been approved for marketing) within 3 months of the first administration of investigational product
• - Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
• - Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent
• - Receipt of any marketed (e.g., omalizumab, mepolizumab etc.) or investigational biologic within 4 months or 5 half-lives prior to the date informed consent
• - Receipt of live attenuated vaccines 30 days prior to randomization on Day 1
• - Current malignancy, or history of malignancy except (basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
• - Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
• - Use of antacids, analgesics (except paracetamol/acetaminophen), herbal remedies, mega-dose vitamins (20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer
• - Previous receipt of received benralizumab
• - Any ongoing or recent minor medical complaints
• - Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order