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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01537653 | Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects | PHASE1 | COMPLETED | 32 | — | — | Mar 1, 2012 | Oct 1, 2012 | Dec 6, 2013 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| SAR231893 (REGN668), Dose Level 4 | EXPERIMENTAL | Dose Level 4 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| SAR231893 (REGN668), Dose Level 1 | EXPERIMENTAL | Dose Level 1 |
| SAR231893 (REGN668), Dose Level 2 | EXPERIMENTAL | Dose Level 2 |
| SAR231893 (REGN668), Dose Level 3 | EXPERIMENTAL | Dose Level 3 |
| Name | Type | Description |
|---|---|---|
| SAR231893 (REGN668) | DRUG | Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection |
| placebo | DRUG | Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection |
Inclusion criteria: * Japanese adult male subjects, between 20 and 45 years of age, inclusive. * Body weight between 50.0 and 95.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment. * Having given written informed co...