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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01209793 | Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers | PHASE1 | COMPLETED | 40 | — | — | Nov 1, 2010 | Sep 1, 2011 | Jun 1, 2012 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| Dose 1 | EXPERIMENTAL | (3:1, active: placebo) |
| Dose 2 | EXPERIMENTAL | (3:1, active: placebo) |
| Dose 3 | EXPERIMENTAL | (3:1, active: placebo) |
| Dose 4 | EXPERIMENTAL | (3:1, active: placebo) |
| Dose 5 | EXPERIMENTAL | (3:1, active: placebo) |
| Name | Type | Description |
|---|---|---|
| REGN846 | BIOLOGICAL | 5 IV cohorts (Dose 1, 2, 3, 4, 5) |
Inclusion Criteria: * Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile * Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive * Normal vital signs after resting in a sitting position for 5 minutes: * Normal standard 12-lead ECG * Willin...