A Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528

Exclusion Criteria

• - Receipt of MEDI-528 in any previous clinical study;
• - History of allergy or reaction to any component of the study drug formulation or other medications, such as topical lidocaine, administered during bronchoscopy;
• - Lung disease other than allergic asthma (eg, chronic bronchitis);
• - FEV1 < 70% of predicted values;
• - Use of systemic immunosuppressive drugs including systemic corticosteroids (topical corticosteroids are permitted), ICS at doses > 800 μg/day budesonide or equivalent, long-acting β2 agonists (eg, salmeterol), leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline, omalizumab, or any other medication for asthma except short-acting β2 agonist (as needed) within the 4 weeks prior to screening up through administration of study drug;
• - Current use of any β-adrenergic antagonist (eg, propranolol);
• - Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period;
• - Upper or lower respiratory tract infections within 8 weeks before screening;
• - Acute illnesses or evidence of clinically significant active infection, such as fever ≥ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0;
• - Current allergy vaccination therapy (desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline segmental allergen challenge. The allergy vaccination must not include desensitization to the allergen that will be used in the segmental allergen challenge;
• - Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to study drug administration through Study Day 126;
• - Receipt of any therapy with a leukocyte-depleting agent (eg, rituximab, alemtuzumab) unless recovery in white cell count has been documented before screening;
• - Pregnancy (sexually active females must have negative serum and urine pregnancy tests at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
• - Is a nursing mother at the time of screening;
• - Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A;
• - History of significant systemic disease (eg, cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
• - History of cancer other than basal cell carcinoma or cervical carcinoma-in-situ treated with apparently successful curative therapy (remission for ≥ 1 year prior to screening);
• - History of primary immunodeficiency;
• - History of pancreatitis or currently active gastroduodenal ulcer;
• - History of coagulation disorders or abnormal PT and PTT test results at screening;
• - History of life-long urinary retention;
• - History of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to screening or history of smoking of ≥ 10 pack-years;
• - History of anaphylaxis;
• - Elective surgery planned from the time of screening through Study Day 126;
• - Clinically significant abnormalities (other than asthma) upon physical examination prior to study drug administration on Study Day 0;
• - Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at the time of screening;
• - At the time of screening, any of the following: hemoglobin, total white blood cell count (WBC), platelet count, sodium (Na), potassium (K), chloride (Cl), or carbon dioxide (CO2)out of the normal range; aspartate transaminase (AST), alanine transaminase (ALT), blood urea nitrogen (BUN), amylase, lipase, or serum creatinine above the upper limits of normal (ULN); or other abnormal laboratory values in the screening panel that are judged by the principal investigator to be clinically significant; or
• - No detectable levels of IL-9 in the Baseline Visit 2' BAL sample, or any finding upon physical examination or history of any disease that, in the opinion of the principal investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.