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 range18 Years – 75 Years
SexALL
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
✕. 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.
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.
✕. 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.