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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01991509 | Safety and Bioavailability of IV and SC LBR-101 | PHASE1 | COMPLETED | 36 | — | — | Oct 1, 2013 | Jan 1, 2015 | Mar 4, 2015 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| LBR-101 IV Dose 1 | EXPERIMENTAL | LBR-101 Dose 1 Administered Intravenously |
| LBR-101 SC Dose 1 | EXPERIMENTAL | LBR-101 Dose 1 Administered Subcutaneously |
| Placebo IV | PLACEBO_COMPARATOR | Placebo Administered Intravenously |
| Placebo SC | PLACEBO_COMPARATOR | Placebo Administered Subcutaneously |
| LBR-101 Dose 2 IV | EXPERIMENTAL | LBR-101 Dose 2 Administered Intravenously |
| LBR-101 Dose 2 SC | EXPERIMENTAL | LBR-101 Dose 2 Administered Subcutaneously |
| Name | Type | Description |
|---|---|---|
| LBR-101 IV | BIOLOGICAL | LBR-101 Administered Intravenously |
| LBR-101 SC | BIOLOGICAL | LBR-101 Administered Subcutaneously |
Inclusion Criteria: * Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and able to comply with CRU rules regulations and study schedule Exclusion Criteria: * Clinically significant medical or psychiatric condition, Febrile illness within 5 days of dosing, Pregnant...