Asthma
Conditions
Keywords
Amgen, Adolescent, Single Dose, Safety, Pharmacokinetics
Brief summary
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.
Interventions
DRUGAMG 827 or Placebo
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed