Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma

Inclusion Criteria

• Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age
• Body mass index (BMI) between 18 and 35 kg/m^2
• Normal or clinically acceptable physical examination (PE), clinical laboratory values, and electrocardiogram (ECG); clinically acceptable PE includes history of mild atopic asthma
• Used only inhaled short-acting β2-agonists infrequently to treat asthma
• No current exposure to allergens to which subject experiences asthmatic responses
• No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening
• Positive skin prick test to common aeroallergens at screening
• Additional inclusion criteria apply

Exclusion Criteria

• History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
• History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm
• Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks
• Subject has know type I/II diabetes
• History of residential exposure to tuberculosis or has a positive purified protein derivative (PPD) or QuantiFERON test within 4 weeks before randomization
• Subject who has history of malignancy of any type within 5 years prior to enrollment
• Subjects tested positive for drugs/alcohol or nicotine use at screening
• Subjects tested positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
• Additional exclusion criteria apply