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To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo arm | Active Comparator | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
|
| Active arm | Active Comparator | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 181 | Drug | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. | 40 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the area under the plasma concentration curve versus time of drug AMG 181. | 29 Weeks | |
| To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181. | 29 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000591337 | abrilumab |
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| Placebo for AMG 181 | Other | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
|
| To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181. | 29 weeks |
| Bridgeport |
| Connecticut |
| 06606 |
| United States |
| Research Site | Danbury | Connecticut | 06810 | United States |
| Research Site | Miami | Florida | 33143 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | Herston | Queensland | 4006 | Australia |
| Research Site | Adelaide | South Australia | 5000 | Australia |
| Research Site | Prahran | Victoria | 3004 | Australia |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |