Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ERB-257 · 2 trials · 1 indication
| 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...
ERB-257 is an investigational small molecule developed by Pfizer, Inc. It has been studied in Phase 1 clinical trials involving healthy adult volunteers rather than patients with a specific disease. Both of its completed trials evaluated safety and pharmacokinetics after single intravenous doses.
ERB-257 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both of the Phase 1 trials of ERB-257 conducted to date.
ERB-257 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The studies enrolled a combined total of 96 participants, and ERB-257 has not been approved by the FDA.
ERB-257 has been studied in two completed Phase 1 trials. NCT00722501 evaluated ascending single intravenous doses in healthy subjects in the United States, and NCT00722202 evaluated ascending single intravenous doses in healthy Japanese males in Japan. Each trial enrolled 48 participants.
Both ERB-257 trials were randomized, double-blind, and placebo-controlled Phase 1 studies of ascending single intravenous doses in healthy volunteers. NCT00722501 enrolled adults aged 18 and older of any sex in the United States, while NCT00722202 enrolled Japanese males aged 20 and older in Japan.