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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01484600 | Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers | PHASE1 | COMPLETED | 36 | — | — | Dec 1, 2011 | Feb 1, 2012 | Mar 14, 2012 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| REGN668: Injection Rate 1 | DRUG | Subjects will receive REGN668 via SC injection |
| REGN668: Injection Rate 2 | DRUG | Subjects will receive study drug via alternate delivery (if necessary) |
Inclusion Criteria: 1. Male or female subjects 18 to 55 years of age. 2. Body weight between 60 kg and 80 kg, body mass index between 20 and 30 kg/m2 inclusive. 3. NHV as evidenced by comprehensive clinical assessment (detailed medical history and complete physical examination). 4. Normal resting b...