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The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part B | Experimental | One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease. |
|
| Part A | Experimental | Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 139 | Drug | Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139 | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD | 36 weeks |
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Inclusion Criteria:
Part A - Healthy Subjects:
Part B - Crohn's Subjects:
Exclusion Criteria:
Parts A - Healthy Subjects:
Part B only - Crohn's Subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States | ||
| Stony Brook University Medical Center |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000600954 | AMG 139 |
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| Stony Brook |
| New York |
| 11794 |
| United States |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73102 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23291 | United States |
| QPharm Pty Limited | Herston | Queensland | 4029 | Australia |
| Clinical Medical and Analytical eXellence CMAX | Adelaide | South Australia | 5000 | Australia |
| Centre for Clinical Studies (Alfred) | Prahran | Victoria | 3181 | Australia |
| D007410 | Intestinal Diseases |