A Randomized Double-Blind Placebo-Controlled Sequential Phase I Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects with Hypertrophic Obstructive Cardiomyopathy
Brief description of study
The purpose of the study is to determine the safety and tolerability of CT-G20 (the study drug) in subjects with obstructive hypertrophic cardiomyopathy (oHCM). The study will also determine how the drug is distributed within your body and some of its effects on your body. Hypertrophic cardiomyopathy (HCM) is a condition in which heart muscle becomes abnormally thick. HCM can be classified as obstructive or non-obstructive depending upon outflow of the blood from left ventricle (one of four chambers of the heart responsible for pumping oxygenated blood into body). Sometimes, the septum, the wall that divides the left and right side of the heart, thickens and bulges into the left ventricle. This can block blood flow out of the left ventricle causing the ventricle to work harder to pump blood. This is known as oHCM. Currently, the management of oHCM symptoms ranges from lifestyle modification to surgery. Available treatments for oHCM are not optimal as they do not adequately target the mechanisms responsible for oHCM symptoms in the majority of subjects. In addition, long-term use of current treatments is limited by limited efficacy and side effects. Current treatments also do not prevent progression of oHCM to heart failure.
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