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A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 282 | Experimental | AMG 282 administered as subcutaneous and intravenous doses. |
|
| Placebo | Placebo Comparator | No active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 282 | Drug | AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs) | 169 days |
| Immunogenicity | Subject incidence of anti-AMG 282 antibodies | 169 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of AMG 282 | Serum concentrations and derived PK parameters (eg, time to maximum concentration [tmax], area under the concentration-time curve over the dosing interval Ï„ [AUCÏ„] after the first and last dose, and maximum observed concentration [Cmax]). | 169 days |
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Healthy Volunteers:
Inclusion Criteria:
Exclusion Criteria:
Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP):
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Santa Monica | California | 90404 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| Placebo | Drug | Contains no active drug |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Research Site | South Miami | Florida | 33143 | United States |
| Research Site | Houston | Texas | 77030 | United States |