At a glance
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A Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586881 in Patients With Acute Lung Injury
In Brief
A Phase 2 clinical trial evaluating Dose 1 GSK2586881, Dose 2 GSK2586881, and 3 other interventions for Lung Injury, Acute. Completed, enrolled 44 participants across 19 sites in 2 countries.
Detailed Summary
This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The study has two parts: Part A will be an open-label investigation in five subjects. Part B will be a double-blind, placebo controlled investigation and will involve approximately 60 subjects.
Study Details
Timeline
Interventions
Low dose GSK2586881 administered intravenously
Medium dose GSK2586881 administered intravenously
Medium-High dose GSK2586881 administered intravenously
High dose GSK2586881 administered intravenously
Administered intravenously to match intervention