Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01258205 | Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects | PHASE1 | COMPLETED | 48 | — | — | Feb 28, 2011 | Feb 18, 2015 | May 10, 2021 | 7 | United States, Australia |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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). |
Inclusion Criteria: Part A - Healthy Subjects: * Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age * Body mass index (BMI) between 18 and 32 kg/m2 * Normal or clinically acceptable physical examination, clinical laboratory values, and ECG * Additional incl...