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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01537640 | Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 2012 | Jul 1, 2012 | Dec 6, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| SAR231893 (REGN668) Drug Product (DP) 1 | EXPERIMENTAL | SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection |
| SAR231893 (REGN668) Drug Product (DP) 2 | EXPERIMENTAL | SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| SAR231893 (REGN668) DP1 | BIOLOGICAL | Pharmaceutical form:solution Route of administration: subcutaneous |
| SAR231893 (REGN668) DP2 | BIOLOGICAL | Pharmaceutical form:solution Route of administration: subcutaneous |
Inclusion criteria: * Healthy male and female subjects between 18 and 45 years of age Exclusion criteria: * Presence or history of drug hypersensitivity or allergic disease * History or presence of dermatological disorders * Fever or persistent chronic or active recurring infection requiring trea...