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The study had been cancelled and replaced with protocol 20130250.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 2 | Experimental | Adolescents - Ages 13 to <17 |
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| Cohort 1 | Experimental | Adolescents - Ages 12 to <13 |
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| Cohort 4 | Experimental | Adults - Ages 18 to <=50 |
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| Cohort 3 | Experimental | Adolescents - Ages 17 to <18 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 827 or Placebo | Drug | A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC). |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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| Intermittantly throughout the duration of the study, an expected average of 5 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |