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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01587365 | Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins | PHASE1 | COMPLETED | 66 | — | — | May 1, 2012 | May 1, 2013 | Sep 4, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 0.01 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 2: BMS-962476 SC (0.03 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 0.03 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 3: BMS-962476 SC (0.1 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 4: BMS-962476 SC (0.3 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 5: BMS-962476 IV (0.3 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day |
| Panel 6: BMS-962476 IV (1.0 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 1.0 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day |
| Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or Placebo | EXPERIMENTAL | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Name | Type | Description |
|---|---|---|
| BMS-962476 | BIOLOGICAL | - |
| Placebo matching with BMS-962476 | BIOLOGICAL | - |
Inclusion Criteria: * Healthy population * Untreated low density lipoprotein cholesterol (LDL-c) ≥ 130 and ≤ 190 mg/dL and triglycerides ≤ 200 mg/dL * Body Mass Index (BMI) of 18 to 35 kg/m2 inclusive * Men and women, ages 18 to 65 years, inclusive * Statin population * Patients with hype...