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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01516450 | Japanese phase1 Study of Belimumab (IV vs SC) | PHASE1 | COMPLETED | 16 | — | — | Dec 26, 2011 | Apr 11, 2012 | Jun 12, 2017 | 1 | Japan |
| NCT01381536 | Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE) | PHASE1 | COMPLETED | 12 | — | — | Jul 20, 2010 | Nov 27, 2010 | Jun 12, 2017 | 2 | Japan |
Systolic and diastolic blood pressure, pulse rate, body temperature
CD20+, immunoglobulin
Presence of anti belimumab antibody
ECGs, clinical laboratory test, local tolerance evaluation (injection site), and adverse events
Number of subjects with adverse events (AE) as meaasure of safety and tolerability
| Arm | Type | Description |
|---|---|---|
| GSK1550188 200mg for SC | ACTIVE_COMPARATOR | Single SC dose of belimumab 200mg |
| GSK1550188 200mg for IV | ACTIVE_COMPARATOR | Single IV dose of belimumab 200 mg |
| GSK1550188 1mg/kg or 10mg/kg | EXPERIMENTAL | one shot IV |
| Name | Type | Description |
|---|---|---|
| GSK1550188 IV | DRUG | Single IV dose of belimumab 200 mg |
| GSK1550188 SC | DRUG | Single SC dose of belimumab 200mg |
| GSK1550188 1mg/kg or 10mg/kg | DRUG | IV one shot |
Inclusion Criteria: * Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. Rationale: Set for the...