A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic Asthma

Exclusion Criteria

• •Active lung disease other than asthma
• •Asthma exacerbation requiring treatment with the addition of systemic (oral or IV) corticosteroids or an increase in systemic corticosteroids within 1 month prior to screening or during the run-in period
• •Significant change (e.g., 50% change) in dosage of inhaled corticosteroids in daily dose or dosing schedule within 1 month of prior to the screening visit or during the run-in period
• •Significant medical illness other than asthma
• •Treatment with methotrexate, gold salts, cyclosporine, theophyllines, or macrolide antibiotics within 3 months prior to screening or during the run-in period
• •Treatment with HAE1
• •Any treatment with omalizumab
• •Known hypersensitivity to the ingredients of the HAE1 formulation, to trial rescue medication (albuterol), or related drugs
• •History of acute infectious sinusitis or respiratory tract infection within 1 month prior to screening or during the run-in period
• •Aspirin or other nonsteroidal anti-inflammatory drug-related asthma
• •Allergy vaccination therapy \< 3 months of stable maintenance dose prior to screening
• •Treatment with oral or parenteral corticosteroids within 1 month prior to screening or during the run-in period
• •Current treatment with \<beta\>-blocker medications (e.g., propranolol)
• •Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
• •Abnormal chest X-ray (excluding changes consistent with asthma) within 12 months prior to screening
• •Clinically significant or active systemic disease (e.g., cancer, neoplasia, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular diseases, or endocrine or gastrointestinal disease) within 3 months of screening or during the run-in period
• •Inability or unwillingness to comply with study procedures and visits (e.g., spirometry, blood draws, subject diary)
• •History of drug or alcohol abuse
• •Elevated serum IgE levels for reasons other than allergy (e.g., parasitic infection, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis)
• •Pregnancy or lactation
• •Platelet count ≤ 110,000/mm\^3 or ≤ 110 x 10\^9/L at screening or the qualifying run-in visit
• •Clinically significant laboratory abnormalities, which would limit participation in the study or interfere in the interpretation of study, or affect subject safety, and evaluations at screening or the qualifying run-in visit
• •Treatment with an investigational drug within 1 month of screening or during the run-in period