Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB-240563 · 1 trial · 1 indication
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...
SB-240563 is a monoclonal antibody being developed for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it is an investigational drug and has not yet been approved for use. The drug is being studied in patients with asthma to evaluate its safety and tolerability.
SB-240563 is being developed by GSK plc, a global pharmaceutical company. GSK is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for the treatment of asthma.
SB-240563 is currently in Phase 1 clinical development. This is the earliest stage of testing in humans, primarily focused on assessing the drug's safety, tolerability, and pharmacokinetics. The drug is investigational and has not been approved by regulatory authorities for commercial use.
SB-240563 has been studied in one completed clinical trial, identified as NCT01471327. This was a Phase 1 study conducted in Australia, enrolling 35 male participants aged 20 years and older, including healthy volunteers. The trial was controlled but not double-blinded, and it focused on the drug's use in asthma.
SB-240563 is also known as mepolizumab, as indicated by the clinical trial title 'Japanese Phase 1 Study of Mepolizumab'. This confirms that SB-240563 is an alternative name for the drug mepolizumab, which is being developed by GSK for the treatment of asthma.