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

This is an interventional treatment trial for Asthma focused on measuring Asthma, Chronic Obstructive pulmonary Disease, Pharmacokinetics, Healthy volunteers Read More

Inclusion Criteria:

• Healthy male and/or female subjects of non-child-bearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
• Females must be non pregnant,non lactating and non-child-bearing potential, confirmed at screening
• Sexually active male willingness to use contraception
• Body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 55 kg and no more than 100 kg inclusive.

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