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

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

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.

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.