Study of Injectable IMC-001 to Improve Atherosclerotic Plaque Stability in Adults With Acute Coronary Syndrome

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of an injectable drug called IMC-001 in improving the stability of atherosclerotic plaques in patients diagnosed with acute coronary syndrome ACS, which includes conditions like acute myocardial infarction or unstable angina. This early phase 1, randomized, double-blind, placebo-controlled study is being conducted at two centers and aims to better understand how IMC-001 affects plaque stability in these patients. The study involves two dose groups with nine subjects each, where six receive IMC-001 plus optimal medical therapy and three receive a placebo plus optimal medical therapy. Participants will receive injections of either IMC-001 or placebo alongside standard treatments for coronary artery disease. The trial includes a dose escalation design to assess safety and preliminary efficacy. Participants will be monitored for changes in coronary artery low-attenuation plaque volume using coronary computed tomography angiography CCTA at baseline and again six months after treatment. The study will track safety, plaque volume changes, and other clinical assessments during the treatment and follow-up periods. The total participation duration includes the treatment phase and a six-month evaluation after dosing to assess the primary outcome measure.

A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.