A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response with Atopic Asthma

Exclusion Criteria

• - Receipt of MEDI-528 in any previous clinical study;
• - History of allergy or adverse reactions to any component of the MEDI-528 formulation;
• - Lung disease other than allergic asthma (e.g. chronic bronchitis);
• - Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting β2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting β2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0.
• - Current use of any β-adrenergic antagonist (e.g. propranolol).
• - Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
• - Acute illnesses or evidence of clinically significant active infection, such as fever ³ 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 (i.e., desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline allergen inhalation challenge;
• - Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
• - Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
• - Pregnancy (sexually active females must have a negative serum pregnancy test 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 study enrollment;
• - 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 (e.g., cancer; infection; coronary artery disease or other cardiovascular disease; or hematological, renal, hepatic, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
• - History of cancer other than nonmelanoma skin cancer or cervical carcinoma-in-situ that have been treated successfully with curative therapy;
• - History of primary immunodeficiency;
• - History of pancreatitis;
• - History of use of tobacco products within 2 years of baseline or history of smoking >= 10 pack-years;
• - 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 abnormalities: aspartate transaminase (AST), alanine transaminase (ALT), or amylase > 1.5 × above the upper limits of normal (ULN); or serum creatinine > 1.3 × ULN; or any other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator (PI), are judged to be clinically significant; or
• - Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the PI or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.