AtherosclerosisEarly Phase 1NCT06788431
A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
A Early Phase 1 study testing IMC-001 and Optimal medical treatment in people with Atherosclerosis, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- IMC-001 and Optimal medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 10 Mar 2025to 30 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
- 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; subjects with alcohol abuse defined as consuming 14 units of alcohol weekly: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan
86-0377-63328795, nyyzgcp@163.com
- Recruiting
Renji Hospital,Shanghai
Shanghai, Shanghai Municipality
About this study
Official title: A Two-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Investigator-Initiated Trial (IIT) Evaluating the Safety and Preliminary Efficacy of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
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
- Being tested
- IMC-001 and Optimal medical treatment, IMC-001 placebo and optimal medical treatment
- Keywords
- Acute coronary syndrome, atherosclerosis
- Medical subject headings
- Atherosclerosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-001 and Optimal medical treatmentDrug
Subjects receive IMC-001 administered by injection and also receive optimal medical treatment.
IMC-001 placebo and optimal medical treatmentDrug
Subjects receive IMC-001 placebo administered by injection and also receive optimal medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| IMC-001 and Optimal medical treatment | Experimental | Not described Receives: Drug: IMC-001 and Optimal medical treatment |
| IMC-001 placebo and Optimal medical treatment | Placebo comparator | Not described Receives: Drug: IMC-001 placebo and optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 176
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start10 Mar 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd., First Affiliated Hospital of Nanyang Medical College
- Responsible party
- Sponsor
- Investigators
- Jun Pu, M.D., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788431
- Sponsor's protocol ID
- IMC-001-01
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Investigator-Initiated Trial (IIT) Evaluating the Safety and Preliminary Efficacy of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT06788431
- Acronym / sponsor ID
- IMC-001-01
- Conditions
- Atherosclerosis
- Keywords
- Acute coronary syndrome, atherosclerosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Collaborators
- RenJi Hospital, ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd., First Affiliated Hospital of Nanyang Medical College
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-001 and Optimal medical treatmentSubjects receive IMC-001 administered by injection and also receive optimal medical treatment. | Drug | IMC-001 and Optimal medical treatment |
| IMC-001 placebo and optimal medical treatmentSubjects receive IMC-001 placebo administered by injection and also receive optimal medical treatment. | Drug | IMC-001 placebo and Optimal medical treatment |
Primary outcome
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)
Time frame: Day 176
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Pu, M.D. principal investigator
RenJi Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IMC-001 and Optimal medical treatment in people with Atherosclerosis, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, M.D. (86-13817577592, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Day 176). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.