A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.

NCT06788431 | Recruiting Early Phase 1 DMC

• 1 other identifier: IMC-001-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atherosclerosis

Keywords

Acute coronary syndrome; atherosclerosis

Outcome Measures

Primary Outcomes (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)

  Day 176

Study Arms (2)

IMC-001 and Optimal medical treatment

EXPERIMENTAL

Drug: IMC-001 and Optimal medical treatment

IMC-001 placebo and Optimal medical treatment

PLACEBO COMPARATOR

Drug: IMC-001 placebo and optimal medical treatment

Interventions

IMC-001 placebo and optimal medical treatment DRUG

Subjects receive IMC-001 placebo administered by injection and also receive optimal medical treatment.

IMC-001 placebo and Optimal medical treatment

IMC-001 and Optimal medical treatment DRUG

Subjects receive IMC-001 administered by injection and also receive optimal medical treatment.

IMC-001 and Optimal medical treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ① Patients with ≥30% and \<70% stenosis in the target vessel as demonstrated by coronary angiography or coronary CTA;
• ② At least one plaque exhibiting detectable low attenuation (coronary CTA -30 HU to 30 HU), with calcified volume constituting \<50% of total plaque volume;
• ③ High-sensitivity C-reactive protein (hsCRP) ≥ 1.0 mg/L;
• 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.

You may not qualify 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 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.
• Moderate to severe renal impairment, defined as: estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m²at screening (calculated using the 2021 CKD-EPI formula; see Appendix 4), or serum creatinine \> 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 laboratory parameters within 7 days without transfusion, including but not limited to: white blood cell count below the lower limit of normal, neutrophil count \<1.5×109/L, haemoglobin \<100 g/L, platelet count ≤100×109 /L, total bilirubin \>1.5×ULN, International Normalised Ratio (INR) \>2×ULN, or activated partial thromboplastin time (APTT) \>2×ULN.
• 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.

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead
• ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.: collaborator
• The First Affiliated Hospital of Nanyang Medical College: collaborator
• RenJi Hospital: collaborator

Study Sites (2)

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

RECRUITING

Renji Hospital,Shanghai

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Acute Coronary Syndrome

Interventions

IMC-001

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Study Officials

• Jun Pu, M.D.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu, M.D.

CONTACT

86-13817577592; pujun310@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: nine subjects were enrolled in each dose group, including 6 in the experimental group and 3 in the control group. The experimental group received IMC-001 and optimal drug treatment, and a total of 12 subjects were included, and the control group was given placebo and optimal drug treatment, and a total of 6 subjects were included

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 23, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (2)