A two-center, randomized, double-blind, placebo-controlled, dose-escalation IIT clinical study evaluating the safety and preliminary efficacy of injectable IMC-001 in improving atherosclerotic plaque stability in patients with acute coronary syndrome. The plan is to conduct 2 dose groups, with 9 subjects enrolled in each group, including 6 in the treatment group and 3 in the control group. The treatment group will receive IMC-001 along with optimal drug therapy, with a total of 12 subjects included, while the control group will receive a placebo along with optimal drug therapy, with a total of 6 subjects included.
Fully comprehend the purpose, characteristics, methodology, and potential adverse reactions of this study; voluntarily participate in the research and sign an informed consent form prior to any related assessments;
Male or female subjects aged ≥18 years and ≤75 years;
Patients must receive guideline-directed standard treatment for coronary artery disease;
Women of childbearing potential or men (unless their partner is infertile) must agree to use medically approved contraception from screening until 6 months after the last dose; Male subjects must not donate sperm, and female subjects must not donate eggs for at least 6 months after signing the informed consent form and until 6 months after the last dose.
Participation in any drug or medical device clinical trial within one month prior to screening.
Previous treatment with coronary artery bypass grafting (CABG), left ventricular assist device (LVAD) implantation, heart transplantation, surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement (TAVR), or any planned procedure for these treatments during the study period.
New York Heart Association (NYHA) functional class III or IV, or a known recent left ventricular ejection fraction (LVEF) < 40% (as determined by left ventricular angiography, radionuclide ventriculography, or echocardiography).
Uncontrolled arrhythmia within 3 months prior to screening, defined as recurrent, symptomatic, and refractory to medical therapy, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia, or a family history of long QT syndrome.
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Lead sponsor
RenJi Hospital
Collaborator
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Collaborator
The First Affiliated Hospital of Nanyang Medical College
Collaborator