Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; Tezepelumab
Intervention description: Administered in a 1-hour intravenous infusion; Administered in a 1-hour intravenous infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Amgen; AMG 157; Asthma

Summary:

      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.
    

Eligibility 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/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