Actively Recruiting
A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
Led by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Updated on 2026-04-15
18
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
Sponsors
I
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study purpose, methods, and potential risks, and provide informed consent before assessments
- Male or female aged 18 to 75 years
- Diagnosed with acute coronary syndrome (including heart attack or unstable angina)
- Have 30% to less than 70% stenosis in the target vessel shown by coronary angiography or coronary CTA
- Have at least one plaque with low attenuation (−30 HU to 30 HU) and calcified volume less than 50% of total plaque volume
- Have high-sensitivity C-reactive protein (hsCRP) of 1.0 mg/L or higher
- Receiving guideline-directed standard treatment for coronary artery disease
- Agree to use medically approved contraception from screening until 6 months after last dose if woman of childbearing potential or partner is fertile
You will not qualify if you...
- Participated in any drug or medical device trial within 1 month before screening
- Previous coronary artery bypass grafting, heart assist device, heart transplant, or planned major heart surgeries during the study
- New York Heart Association class III or IV, or left ventricular ejection fraction below 40%
- Uncontrolled arrhythmias in the last 3 months, including certain types of tachycardia or atrial fibrillation
- Active or suspected cancer within 3 years, except certain skin cancers, with life expectancy under 1 year
- Major surgery within 3 months before screening or planned during the study
- Severe infections within 8 weeks before dosing or chronic infections requiring treatment
- Severe liver dysfunction with ALT or AST more than 3 times the upper normal limit
- Moderate to severe kidney impairment with eGFR below 45 mL/min/1.73 m2 or high serum creatinine
- Autoimmune diseases or planned systemic anti-inflammatory therapies
- Significant recent blood loss, abnormal blood counts, or coagulation issues
- Known allergy to related proteins, IMC-001, or similar drugs
- Contraindications to coronary CTA or iodine contrast allergy
- High coronary artery calcium score (300 or more) or vessel tortuosity affecting assessments
- Vaccination within 1 month before screening or planned during treatment
- Recent substance or alcohol abuse
- Pregnant or breastfeeding women or positive pregnancy test at screening
- Any other condition making the participant unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Actively Recruiting
2
Renji Hospital,Shanghai
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jun Pu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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