Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Subjects With Mild Atopic Asthma

20101183

The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.

2011-10-31

2013-04-05

2013-04-05

Completed

Early phase I

31

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

2022-10-17