Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
Brief 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.


Options:
A: 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
B: Inclusion Criteria:

* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
* Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
* MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA115575.
* Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., inhaled corticosteroids \[ICS\] or other asthma controlled medication) and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study.
* Male or eligible female subjects:
* To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration.
* A serum pregnancy test is required of all females at the initial Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.

Exclusion Criteria:

* Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
* Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
* Malignancy: A current malignancy or malignancy that developed during MEA115588 or MEA115575 (subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). \[Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded\]
* Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
* Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
* ECG: Baseline ECG which has a clinically significant abnormality or which shows corrected QT interval with Fridericia (QTcF) \>=450 millisecond (msec) or QTcF \>=480 msec for subjects with Bundle Branch Block.
* Smoking status: Current smokers
* Liver Function: Liver function tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 : alanine transaminase (ALT) \>=2 x upper limit of normal (ULN); aspartate transaminase (AST) \>=2 x ULN; alkaline phosphatase \>=2 x ULN; Bilirubin \>1.5 x ULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%
* Hepatitis Status: Positive Hepatitis B Surface Antigen (HBsAg) screen at Visit 1
* ECG Over-read: Clinically significant abnormality identified during the central over-read during one of the last treatment visits in MEA115588 or MEA115575
C: Inclusion Criteria:

* Non-smoking subjects
* 6-26 years of age
* Evidence of poor asthma control
* Adherence to ICS \< 50% of doses prescribed over a minimum of 3 months
* Baseline FEV1 \> 60% of predicted
* PC20 AMP \< 60 mg/ml
* Able to perform American Thoracic Society (ATS)-acceptable and reproducible spirometry

Exclusion Criteria:

* Cigarette smoking/use of marijuana
* Pregnancy
* Respiratory infections in past six weeks
* History of acute allergic reaction to asthma/allergy medication
* Total dose requirement of omalizumab more than 375 mg every two weeks
* Inability to withhold required medications before challenge
* Abnormal electrocardiogram (ECG)
D: Inclusion Criteria:

* Adult patients, 18 to 75 years of age inclusive
* Body weight \>/= 40 kg
* Physician's diagnosis of asthma for at least 12 months
* Evidence of documented bronchodilator reversibility as defined by protocol
* Prebronchodilator FEV1 \>/= 40% and \</= 80% predicted at Visit 1
* Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
* History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
* Inadequately controlled asthma despite compliance with asthma controller therapy

Exclusion Criteria:

* Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
* Pre-existing active lung disease other than asthma
* Any infection
* Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
* Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
* Current substance abuse
* Former smoker with \>10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
* History of anaphylaxis
* Pregnant and lactating women

Answer: A