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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00722202 | Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2008 | Nov 1, 2008 | Apr 28, 2009 | 1 | Japan |
| NCT00722501 | Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257 | PHASE1 | COMPLETED | 48 | — | — | Aug 1, 2008 | Nov 1, 2008 | Apr 28, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| ERB-257 | ACTIVE_COMPARATOR | 7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1, 4, 15, 45, 90, 180, and 300 mg |
| placebo | PLACEBO_COMPARATOR | 2 placebo subjects per group |
| Name | Type | Description |
|---|---|---|
| ERB-257 | DRUG | - |
| placebo | OTHER | - |
Inclusion Criteria: 1. Healthy Japanese men between the ages of 20 and 50. 2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg2. 3. Have a high probability for compliance with and completion of the study. Exclusion Criteria: 1. Presence or hi...