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

Amgen

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Drug: Placebo

Biological: Tezepelumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01405963

20101183

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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