S5-4 Phase I, heart failure clinical trial to evaluate the safety of SG1002 – A novel hydrogen sulfide donor

Abstract

Hydrogen sulfide, an endogenous gaseous 2nd messenger shown to mediate numerous physiological actions, is reduced in heart failure patients. We have recently developed a novel hydrogen sulfide precursor/donor, SG1002, which we have previous shown increases circulating hydrogen sulfide levels and improves cardiac function and decreases disease in murine models of heart failure. To test whether SG1002 is capable of overcoming sulfide deficits in heart failure patients, we have recently undertaken a double-blind, placebo-controlled Phase I dose escalation study. Doses ranging from 200–800 mg BID for 1 week were all well tolerated in normal healthy subjects, with side effects limited to nausea at the highest dose. Clinical blood chemistries, urinalysis and ECG were all unchanged. Analyses of pharmacokinetics and markers of oxidative stress are currently underway and will be reported. Based on the safety in this population, we are now repeating this study in heart failure subjects (Age 35–85, NYHA class II or III, EF