Double-blind, Multiple Dose Study in Subjects With Mild Atopic Asthma

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the late asthmatic response, safety and tolerability of AMG 157 following multiple intravenous (IV) dose administration in subjects with mild atopic asthma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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/m2

• Normal or clinically acceptable physical examination (PE), clinical laboratory values, and 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 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 HIV, Hep B or Hep C

• Additional exclusion criteria apply