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To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Ten escalating dose levels of AMG 181 administered as a single dose SC or IV in healthy volunteers and SC in subjects with mild-to-moderate ulcerative colitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amg 181 | Drug | Ten escalating dose levels of AMG 181 administered as single dose SC or IV, in healthy volunteers and SC subjects with mild-to-moderate ulcerative colitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC) | Through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181 | Through study completion | |
| To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations | Through study completion |
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Inclusion Criteria: Healthy Volunteers
Inclusion Criteria: Subjects with Mild to Moderate Ulcerative Colitis
Exclusion criteria: Healthy Volunteers
Exclusion criteria: Subjects with Mild to Moderate Ulcerative Colitis
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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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| Danbury |
| Connecticut |
| 06810 |
| United States |
| Research Site | Plymouth | Minnesota | 55446 | 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 |
| Research Site | Nedlands | Western Australia | 6009 | Australia |
| Research Site | Auckland | 1023 | New Zealand |
| Research Site | Christchurch | 8011 | New Zealand |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000591337 | abrilumab |
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