Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW328267X · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg), and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg) |
| Cohort 2 | EXPERIMENTAL | Dose to be determined after analysis of Cohort 1 |
| Name | Type | Description |
|---|---|---|
| Saline | DRUG | 30mins run-in period |
| GW328267X (total dose of 12mcg) | DRUG | 8 mcg/h for 1.5 hours (total dose of 12mcg) |
| GW328267X (total dose of 40mcg) | DRUG | 10 mcg/h for 4 hours (total dose of 40 mcg) |
Inclusion Criteria: * Healthy 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 reference range ...
GW328267X is an investigational small molecule developed by GSK plc for acute lung injury. It was studied as an intravenous infusion in a Phase 1 clinical trial in healthy volunteers. The compound has been evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics, and it is not an approved medicine.
GW328267X was studied for acute lung injury, a serious respiratory condition. The only recorded clinical trial enrolled healthy volunteers rather than patients with the condition, and it assessed safety, tolerability, pharmacokinetics, and pharmacodynamics of an intravenous infusion. No approved use for GW328267X in acute lung injury or any other indication has been established.
GW328267X is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 study of the compound. The drug is an investigational small molecule in the respiratory therapeutic area, and no partner or licensee for the asset is identified in the clinical record.
GW328267X is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. Because the program has not advanced beyond early clinical testing, GW328267X is investigational and has not been approved by the FDA or any other regulator for acute lung injury or any other use.
GW328267X has been studied in one completed Phase 1 trial, NCT01640990, titled A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers. It enrolled 3 healthy male volunteers aged 18 years and older in the United Kingdom. No trials are currently active.