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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00991159 | A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects | PHASE1 | COMPLETED | 48 | — | — | Nov 1, 2009 | May 1, 2010 | Jul 4, 2012 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| RN316 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RN316 | BIOLOGICAL | Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg. |
Inclusion Criteria: * Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive. * Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl. * BMI 18.5 to 35, and body weight ≤150 kg, inclusive. Exclusion Criteria: * Evidence of clinically significant disease...