Lung Injury, Acute Clinical Trial
Official title:
A Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586881 in Patients With Acute Lung Injury
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.
The acute respiratory distress syndrome (ARDS) is a form of severe acute lung injury (ALI)
characterized by hypoxemic respiratory failure (the lungs are unable to absorb oxygen to the
arterial blood) and non-cardiogenic pulmonary edema (accumulation of fluid in the lungs). The
syndrome may be caused by direct or indirect injury to the lungs. It is associated with a
mortality rate of up to 40-50%. There are no marketed pharmacologic therapies for this
devastating syndrome.
This study aims to assess the safety, tolerability and pharmacodynamics of GSK2586881, a
recombinant human angiotensin converting enzyme type 2 (rhACE2).
ACE2 is involved in the Renin-Angiotensin System (RAS), which controls blood pressure,
electrolytes and intravascular fluid volume. A key function of rhACE2 is believed to be the
cleavage of Angiotensin II (Ang II) to Ang (1-7), which have opposing physiological roles.
Elevated levels of Ang II are associated with vasoconstriction, inflammation, fibrosis,
vascular leak, and sodium absorption. Ang (1-7) appears to be a counterregulatory protein in
the RAS; associated with vasodilation, anti-proliferation, antiinflammation, and reduced
vascular leak. It has been observed that levels of Ang II are increased in humans with ALI/
ARDS. It is expected that the reduction of Ang II should have a positive impact on ALI and
ARDS.
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