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New treatment option for Atherosclerosis
Official title A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
ClinicalTrials.gov ID: NCT06788431
What this study is testing
What is IMC-001 and Optimal medical treatment?
IMC-001 and Optimal medical treatment is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for atherosclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Fully comprehend the purpose, characteristics, methodology, and potential adverse reactions of this study; voluntarily participate in the research...
- Male or female people aged ≥18 years and ≤75 years;
- Clinically diagnosed with acute coronary syndrome (ACS) (including acute myocardial infarction or unstable angina) and meeting the following...
- 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...
You likely can't join if
- 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...
- New York Heart Association (NYHA) functional class III or IV, or a known recent left ventricular ejection fraction (LVEF) \< 40% (as determined by...
- Uncontrolled arrhythmia within 3 months prior to screening, defined as recurrent, symptomatic, and refractory to medical therapy, such as ventricular...
- Evidence of active or suspected malignancy within 3 years prior to screening (excluding only carcinoma in situ or basal/squamous cell skin cancer...
- Any major surgery within 3 months prior to screening or planned major surgery during the study period;
See the full eligibility 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 people 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: ① Patients with ≥30% and \<70% stenosis in the target vessel as...
- 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 people must not donate sperm, and...
- 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...
- 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...
- 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...
- 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...
- 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.
- Moderate to severe renal impairment, defined as: estimated glomerular filtration rate (eGFR) \ 1.5 × ULN.
- Presence of any type of autoimmune disease; current or planned systemic anti-inflammatory therapy, such as immunomodulatory agents and chemotherapeutic agents.
- Individuals who have donated blood or experienced blood loss ≥400 mL within 3 months prior to dosing, have a history of severe spontaneous bleeding, or have received blood transfusions or blood products. Abnormal...
- Known prior allergy to macromolecular protein preparations/monoclonal antibodies, known allergy to the investigational medicinal product or its excipients or similar drugs, prior treatment with IMC-001.
- Existence of contraindications for CCTA examination and history of iodine contrast agent allergy, etc.
- Screening CCTA reveals moderate to severe calcification (coronary artery calcium score [Agatston score] ≥ 300) or tortuosity in target vessels, judged by the investigator to compromise study assessment.
- Receipt of any type of vaccination within one month prior to screening, or planned vaccination during the study treatment period.
- History of substance abuse (including illicit drug use) and/or alcohol abuse within 6 months prior to screening; people with alcohol abuse defined as consuming 14 units of alcohol weekly: 1 unit = 285 mL beer, 25 mL...
- Pregnant or lactating women; those with a positive pregnancy test during the screening period.
- Any other disease or condition deemed by the investigator to make the subject unsuitable for participation in this study, in addition to those listed above.
The study team makes the final eligibility decision.
Where it's taking place
- Nanyang, Henan, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanyang, Henan, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.