A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; Benralizumab 25 mg; Benralizumab 100 mg; Benralizumab 200 mg
Intervention description: Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.; Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.; Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.; Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
Intervention MeSH terms: Benralizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asthma; Benralizumab; MEDI-563

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of escalating
      multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects

          -  Age 18 through 80 years at screening

          -  Written informed consent and Health Insurance Portability and Accountability Act
             (HIPAA) authorization obtained from the subject prior to performing any
             protocol-related procedures, including screening evaluations

          -  Previously documented diagnosis of asthma of more than or equal to (>=) 1 year
             duration, based on episodic symptoms of airflow obstruction; post-bronchodilator
             reversibility of airflow obstruction >=12 percent (%) (at screening or documented
             within 1 year prior to randomization); or proof of a positive response to a
             methacholine challenge (documented within 1 year prior to randomization) as
             represented by a provoking concentration of methacholine to cause a 20% fall in forced
             expiratory volume in 1 second (FEV1); (PC20) less than (<) 8 milligram per milliliter
             (mg/mL)

          -  Weight of >=45 kilogram (kg) but less than or equal to (<=) 135 kg (>=100 pounds [lb]
             but <=300 lb)

          -  Able to produce spirometry readings that meet American Thoracic Society (ATS)/European
             Respiratory Society (ERS) standards

          -  Screening pre-bronchodilator FEV1 >=60%

          -  Women of childbearing potential, unless surgically sterile (including tubal ligation)
             and/or at least 2 years post-menopausal, must use 2 effective methods of avoiding
             pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine
             device, female condom with spermicide, diaphragm with spermicide, cervical cap,
             abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual
             partner) for 14 days prior to the first dose of the investigational product on Study
             Day 0, and must agree to continue using such precautions through Study Day 161.
             Cessation of birth control after this point should be discussed with a responsible
             physician

          -  Men, unless surgically sterile, must likewise use 2 effective methods of birth control
             (for example, condom with spermicide) and must agree to continue using such
             contraceptive precautions through End of Study/Study Day 161

          -  Ability to complete the study period, including follow-up period until Study Day 161
             as required by protocol

        Exclusion Criteria:

          -  Previously received benralizumab (MEDI-563)

          -  History of allergy or reaction to any component of the investigational product
             formulation

          -  History of allergy or reaction to any other marketed or experimental monoclonal
             antibody therapies, intravenous gammaglobulin (IVIG), or blood products

          -  Receipt of any investigational drug therapy within 30 days prior to randomization into
             the study or any biologic(s) within 5 half-lives of the agent prior to randomization
             into the study

          -  Treatment with an oral or systemic burst of corticosteroids within 4 weeks prior to
             randomization into the study

          -  Use of any chronic systemic immunosuppressive drugs, including oral corticosteroids
             within 4 weeks prior to randomization into the study

          -  Current use of any oral or ophthalmic beta-adrenergic antagonist (for example,
             propranolol), must have been stopped 2 weeks prior to randomization into the study

          -  Current allergy vaccination (immunotherapy)

          -  History of anaphylaxis

          -  Lung disease other than persistent asthma (for example, chronic bronchitis, cystic
             fibrosis, chronic obstructive pulmonary disease [COPD], tuberculosis [TB])

          -  Acute illnesses or evidence of significant active infection, such as fever >=38.0
             degrees Celsius [C] (>=100.5 degrees Fahrenheit [F]) at screening and up through time
             of the first dose of the investigational product

          -  History of ingestion of untreated water in a location known to be infected with
             parasites, resulting in acute or chronic diarrhea; or an untreated parasitic infection
             within 1 month of randomization

          -  Pregnancy (women of childbearing potential must have a negative serum pregnancy test
             at screening and a negative urine pregnancy test prior to administration of the
             investigational product)

          -  Lactating woman

          -  Infection with human immunodeficiency virus (HIV)-1, HIV-2, or hepatitis A, B, or C
             virus

          -  History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix
             treated with apparent success with curative therapy >= 1 year prior to randomization
             into the study

          -  History of cigarette smoking >=10 pack years

          -  History of alcohol abuse or drug abuse that required treatment <1 year prior to
             randomization into the study

          -  Elective surgery planned during the study period

          -  Evidence of any systemic disease or any finding upon physical examination, laboratory
             abnormality, chest x-ray (CXR), or electrocardiogram (ECG) that, in the opinion of the
             investigator or medical monitor, may compromise the safety of the subject in the study
             or confound the analysis of the study results

          -  Employees of the clinical study site or any other individuals involved with the
             conduct of the study, or first degree family members of such individuals (that is,
             parents, siblings, or children)