A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.

Study Overview
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Brief Summary
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The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy subjects and subjects with mild atopic asthma.

Detailed Description
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A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.

Official Title
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A Randomized, Double-Blind, Placebo-controlled, Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Mild Atopic Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: AMG 282
* Drug: AMG 282 Matching Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (All subjects) Is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years. Females must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; OR history of hysterectomy; OR history of bilateral salpingectomy; OR history of bilateral oophorectomy). Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (Subjects with mild atopic asthma only) Documented history of mild, stable atopic asthma within 2 years of screening. Has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) > 70% predicted at screening. Exclusion Criteria (All subjects) History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Principal Investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (PPD) or QuantiFERON test at screening. Subjects with a documented negative PPD or QuantiFERON test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening. Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP. Other criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental Arm<br> | Drug: AMG 282<br>* Single dose either subcutaneously or intravenously on day 1.<br>|
| Placebo Comparator: Placebo Arm<br> | Drug: AMG 282 Matching Placebo<br>* Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events |  | Up to day 141 | 
| Incidence of abnormal clinically significant vital signs |  | Up to day 141 | 
| Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results |  | Up to day 141 | 
| Incidence of abnormal clinically significant ECG results |  | Up to day 141 | 
| Incidence of anti-AMG 282 antibodies |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of various PK parameters including tmax, AUClast and Cmax |  | Up to day 141 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild asthma, Atopic asthma, Healthy volunteers, First-in-human