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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01432717 | Study of ACE-536 in Healthy Postmenopausal Women | PHASE1 | COMPLETED | 40 | — | — | Sep 1, 2011 | Oct 1, 2012 | Nov 7, 2012 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| ACE-536 | EXPERIMENTAL | Subjects assigned to 1 of 5 possible dosing groups. |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ACE-536 | BIOLOGICAL | Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15. |
| Placebo | OTHER | Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15. |
Key Inclusion Criteria: * Postmenopausal women * Body Mass Index (BMI) of 20 - 32 kg/m2. Key Exclusion Criteria: * History of hypertension * Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1 * History of clinically sig...