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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01290042 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. | PHASE1 | COMPLETED | 43 | — | — | Feb 1, 2011 | May 1, 2014 | Mar 17, 2015 | 8 | United States, Australia |
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria: * Body Mass Index (BMI) between 18 and 34 kg/m2 * Normal physical and neurological examination, clinical laboratory values and ECG * Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subj...