This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Unnamed facility
Sevlievo, Gabrovo, Bulgaria
Incidence of Adverse Events
Time frame: Assessed up to Day 7
Left ventricular ejection fraction assessed by 2-D echocardiography
Time frame: Assessed up to 24 hours post-infusion start
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Placebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours