This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
142
Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
Vehicle solution for IV administration single dose.
St. Vincent Hospital
Worcester, Massachusetts, United States
Duke University Hospital
Durham, North Carolina, United States
Madras Medical Mission
Chennai, India
Hinduja Hospital
Mumbai, India
Poona Hospital
Safety as measured by changes in CK-MB
Time frame: within 24 hours
Cardiac biomarkers
Time frame: within 24 hours
ST segment changes
Time frame: within 24 hours
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Pune, India