A FIM Study to Assess Safety and Exposure of Inhaled Single Doses of AP301-A Specific ENaC Channel Activator for the Treatment of Acute Lung Injury

AP301 is an activator of ENaC‐mediated Na+ uptake for the treatment of pulmonary permeability edema in acute respiratory distress syndrome (ARDS). The purpose of this “first‐in‐man” study was to examine local and systemic safety and systemic exposure of ascending single doses of AP301, when inhaled...

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Veröffentlicht in:	Journal of clinical pharmacology 2014-03, Vol.54 (3), p.341-350
Hauptverfasser:	Schwameis, Richard, Eder, Sandra, Pietschmann, Helmut, Fischer, Bernhard, Mascher, Hermann, Tzotzos, Susan, Fischer, Hendrik, Lucas, Rudolf, Zeitlinger, Markus, Hermann, Robert
Format:	Artikel
Sprache:	eng
Schlagworte:	Acute Lung Injury - drug therapy Administration, Inhalation Adult AP301 ARDS Blood Pressure Double-Blind Method ENaC activator Epithelial Sodium Channels - metabolism first-in-man study Health risk assessment Humans Male Nebulizers and Vaporizers Nitric Oxide - metabolism Peptides, Cyclic - administration & dosage Peptides, Cyclic - adverse effects Peptides, Cyclic - blood Peptides, Cyclic - pharmacokinetics Peptides, Cyclic - urine Pulse Respiratory distress syndrome Spirometry Young Adult
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