Actively Recruiting
A Two-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Trial Evaluating the Safety and Preliminary Efficacy of IMC-001 Injection in Acute Coronary Syndrome Patients
Led by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Updated on 2026-04-15
18
Participants Needed
2
Research Sites
N/A
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
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.
CONDITIONS
Brief 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 and agree to participate by signing informed consent
- Male or female aged 18 to 75 years
- Clinically diagnosed with acute coronary syndrome (including acute myocardial infarction or unstable angina)
- Patients with 30% to less than 70% stenosis in the target vessel shown by coronary angiography or coronary CTA
- At least one plaque with detectable low attenuation and less than 50% calcified volume
- High-sensitivity C-reactive protein (hsCRP) level of 1.0 mg/L or higher
- Receiving guideline-directed standard treatment for coronary artery disease
- Agree to use medically approved contraception during the study and for 6 months after last dose if of childbearing potential or partner of such
- Male subjects must not donate sperm, and female subjects must not donate eggs during the same period
You will not qualify if you...
- Participation in any drug or medical device clinical trial within 1 month before screening
- Previous or planned treatments including coronary artery bypass grafting, left ventricular assist device, heart transplant, or aortic valve replacement
- New York Heart Association class III or IV or recent left ventricular ejection fraction under 40%
- Uncontrolled arrhythmia within 3 months before screening
- Active or suspected malignancy within 3 years, except some skin cancers; life expectancy less than 1 year
- Major surgery within 3 months before screening or planned during study
- Severe infections within 8 weeks before dosing or chronic infections needing medical treatment
- Severe liver dysfunction or moderate to severe kidney impairment at screening
- Autoimmune diseases or planned anti-inflammatory therapy
- Significant recent blood loss, abnormal lab parameters without transfusion
- Known allergies to study drugs or similar agents
- Contraindications for coronary CTA or iodine contrast allergy
- Moderate to severe calcification or vessel tortuosity compromising assessment
- Vaccination within 1 month before screening or planned during treatment
- History of substance or alcohol abuse within 6 months
- Pregnant or lactating women or positive pregnancy test at screening
- Any condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive IMC-001 or placebo injections along with optimal medical treatment to improve atherosclerotic plaque stability.
Multiple visits during treatment period
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.
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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