The study enrolled healthy male and female volunteers, who received a single dose of Bendavia administered as an intravenous infusion over an extended period.
Safety trial from the clinical trial and preliminary results showed that Bendavia appears to be safe and well-tolerated at the dose evaluated, without any serious adverse events reported.
Pharmacokinetic analysis from related clinical studies also demonstrated highly predictable dose-proportional exposure of Bendavia among volunteers.
Stealth is currently initiating a multinational Phase II clinical study evaluating Bendavia as a treatment for ischemia reperfusion injury in patients experiencing acute ST-segment elevation myocardial infarction (STEMI).