Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescent (12 to <18 Years) and Adult Subjects With Intermittent or Mild to Moderate Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: AMG 827 or Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and/or female subjects 12 to < 18 years of age at the time of randomization Male and/or female subjects between 18 and 50 years of age (inclusive) at the time of randomization Body weight ≥ 36 kg at screening Intermittent or mild to moderate persistent asthma for at least the past 3 months prior to study enrollment (as defined by the 2004 Global Initiative for Asthma [GINA] guidelines. Exclusion Criteria: Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment. Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma. Use of oral corticosteroids within 3 months prior to study enrollment.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 2<br>Adolescents - Ages 13 to <17 | Drug: AMG 827 or Placebo<br>* A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).<br>|
| Experimental: Cohort 1<br>Adolescents - Ages 12 to <13 | Drug: AMG 827 or Placebo<br>* A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).<br>|
| Experimental: Cohort 4<br>Adults - Ages 18 to <=50 | Drug: AMG 827 or Placebo<br>* A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).<br>|
| Experimental: Cohort 3<br>Adolescents - Ages 17 to <18 | Drug: AMG 827 or Placebo<br>* A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability |  | Participants will be followed for the duration of the study, an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the AMG 827 concentration versus time curve (AUC) for times 0 to infinity (AUC 0-inf) and 0 to last sampling time point (AUC 0-tlast), peak plasma concentration (Cmax) and Time to peak plasma concentration (tmax) will be determined for AMG 827 |  | Intermittantly throughout the duration of the study, an expected average of 5 weeks | 
| Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adult subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability |  | Intermittantly throughout the duration of the study, an expected average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amgen, Adolescent, Single Dose, Safety, Pharmacokinetics