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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01471327 | Japanese Phase 1 Study of Mepolizumab | PHASE1 | COMPLETED | 35 | — | — | Aug 9, 2011 | Apr 27, 2012 | Jun 20, 2017 | 1 | Australia |
Cmax, AUC
vital signs, ECGs, clinical laboratory tests and adverse events
| Arm | Type | Description |
|---|---|---|
| SB-240563, 10mg | EXPERIMENTAL | IV, single dose at Day 1 |
| Placebo | EXPERIMENTAL | Saline IV, single dose at Day 1 |
| SB-240563, 75mg | EXPERIMENTAL | IV, single dose at Day 1 |
| SB-240563, 250mg | EXPERIMENTAL | IV, single dose at Day 1 |
| SB-240563, 750mg | EXPERIMENTAL | IV, single dose at Day 1 |
| Name | Type | Description |
|---|---|---|
| SB-240563 | BIOLOGICAL | 10mg, 75mg, 250mg and 750mg IV, single dose on Day 1 |
| Placebo | OTHER | Saline IV, single dose at Day 1 |
Inclusion Criteria: * Healthy Japanese as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the referen...