Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers
Condition: Asthma; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Benralizumab; Benralizumab
Intervention description: A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.; A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
Intervention MeSH terms: Benralizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Chronic Obstructive pulmonary Disease; Pharmacokinetics; Healthy volunteers

Summary:

      An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable
      drug exposure following Subcutaneous benralizumab administration by using accessorized
      pre-filled syringe (APFS) or autoinjector (AI) devices.
    

Eligibility criteria:

        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