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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01695876 | A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects | PHASE1 | COMPLETED | 58 | — | — | Oct 1, 2012 | Oct 1, 2014 | Mar 4, 2015 | 3 | New Zealand |
Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| AMG 357 | EXPERIMENTAL | AMG 357 is a small molecule for treatment of inflammatory disease |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to AMG 357 containing no active drug |
| Name | Type | Description |
|---|---|---|
| AMG 357 | DRUG | Oral administration available in varying dose strength. |
| Placebo | DRUG | Matching placebo to AMG 357 containing no active drug |
Inclusion Criteria: * Healthy Adult subjects between 25 and 55 years old * Body mass index (BMI) between 18 and 32 kg/m2 * Normal or clinically acceptable physical examination, clinical laboratory values, and ECG * Additional inclusion criteria apply Exclusion Criteria: * Any history or evidence ...