A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patien… (NCT06788431) | Clinical Trial Compass
RecruitingEarly Phase 1
A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
China18 participantsStarted 2025-03-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Clinically diagnosed with acute coronary syndrome (ACS) (including acute myocardial infarction or unstable angina) and meeting the following criteria:
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of changes in coronary artery low-attenuation plaque volume (LAPV) from baseline at 6 months after treatment based on coronary computed tomography angiography (CCTA)
Timeframe: Day 176
Trial details
NCT IDNCT06788431
SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.
. 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.
. Evidence of active or suspected malignancy within 3 years prior to screening (excluding only carcinoma in situ or basal/squamous cell skin cancer treated with curative therapy); life expectancy less than 1 year.
. Any major surgery within 3 months prior to screening or planned major surgery during the study period;
. Presence or suspected ongoing severe infection within 8 weeks prior to first dosing (defined as requiring hospitalisation or intravenous anti-infective therapy), chronic or recurrent bacterial, fungal, or viral infections requiring medical intervention, including syphilis, human immunodeficiency virus (HIV) infection, active hepatitis B or C infection history;
. Presence of severe hepatic dysfunction, defined as: any alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 3 times the upper limit of normal (ULN) at final screening assessment.