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STEMIPhase 1/2NCT06678074

Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI

A Phase 1/2 study testing Atibuclimab (IC14), 20 mg/kg intravenously, once in people with STEMI and STEMI (ST Elevation MI), run by Implicit Bioscience at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atibuclimab (IC14), 20 mg/kg intravenously, once
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
2 sitesUnited States
Study dates
6 Feb 2025to 1 Sep 2026
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG.
  • TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram
  • Symptom onset prior to PCI of ≤12 hours
  • Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI)
  • Ability to infuse study drug within 12 hours of PCI
  • Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms)
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  • Capable of completing study visits
  • Females participating in the study must meet one of the following criteria:
  • Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year);
  • Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or
  • If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) until 30 days after the treatment
  • Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after treatment

Who cannot join

  • An individual fulfilling any of the following criteria is to be excluded from enrollment in the study:
  • Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock)
  • Severe aortic or mitral valve disease
  • Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support
  • Major hemodynamic instability or uncontrolled ventricular arrhythmias
  • Planned or conducted thrombolytic therapy for treatment of this STEMI event
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  • Planned or conducted coronary artery bypass graft
  • Previous major vascular intervention within the last 4 weeks
  • Major surgery within the last 6 weeks
  • Evidence of an active gastrointestinal or urogenital bleeding
  • Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs, or colchicine).
  • Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
  • Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS), but excluding HCV+ with undetectable plasma RNA.
  • Neutropenia (<1,500/mm3 or <1,000/mm3 in Black/African American patients).
  • Active malignancy, excluding carcinoma in situ [any location] or localized non-melanoma skin cancer
  • Participation in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.
  • Life expectancy of less than 1 year due to non-cardiac pathology
  • History of allergic reaction to atibuclimab (IC14), any monoclonal antibody, or any other component used in the study (including contrast media)
  • Body weight >300 pounds (weight limit of the PET/CT table)
  • Known severe renal (creatinine clearance <30 mL/min) or hepatic insufficiency as well as alanine transaminase (ALT) elevation ≥ 3x upper limit of normal; isolated AST-elevation is not considered an exclusion criterion from study participation
  • Any clinically significant abnormality identified at the time of Screening that in the judgment of the Investigator, or any sub-Investigator would preclude safe completion of the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Virginia

    Charlottesville, Virginia, 22908-1394

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase 1b Pilot Study of Atibuclimab (IC14) for Treatment of ST-Elevation Myocardial Infarction

Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared to patients who receive placebo (inactive treatment).

Read the detailed description

Randomized, double-blind, placebo-controlled pilot study to evaluate the safety, exploratory efficacy, and pharmacokinetics of IC14 (atibuclimab) administered via a single IV infusion to patients with STEMI treated with percutaneous intervention. In additional to optional CCR2+ myocardial imaging, biomarkers, cardiac function and patient-reported outcome measures will be reported.

Being tested
Atibuclimab (IC14), 20 mg/kg intravenously, once, Placebo, 150 mL intravenously, once
Keywords
atibuclimab, IC14, monoclonal antibody against CD14, anti-CD14, antiinflammatory
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atibuclimab (IC14), 20 mg/kg intravenously, onceDrug

    monoclonal antibody against CD14

  • Placebo, 150 mL intravenously, onceOther

    sterile normal saline for injection

Study groups in NCT06678074
Study groupRoleWhat they receive
Experimental drug interventionExperimentalmonoclonal antibody against CD14
Receives: Drug: Atibuclimab (IC14), 20 mg/kg intravenously, once
PlaceboPlacebo comparatorIdentical-appearing normal saline for injection, intravenous, once
Receives: Other: Placebo, 150 mL intravenously, once

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (safety and tolerability)

    Treatment-emergent adverse events

    Measured: Day 1-29

Secondary outcomes (13)

  1. CCR2+ cell myocardial infiltration (optional)

    Characterization of CCR2+ cell myocardial infiltration mean standard uptake value (SUVmean) and change from 48 hours measured by myocardial PET/CT imaging at Day 15

    Measured: 48 hours and Day 15

  2. Biomarker C-Reactive Protein

    Change from baseline

    Measured: Day 4, 15, 29

  3. Biomarker White Blood Cell Count

    Change from baseline

    Measured: Day 4, 15, and 29

  4. Biomarker Fibrinogen

    Change from baseline

    Measured: Day 4, 15, 29

  5. Biomarker Interleukin 6

    Change from baseline

    Measured: Day 4, 15, and 29

  6. Biomarker Interleukin-1

    change from baseline

    Measured: Day 4, 15, and 29

  7. Biomarker Troponin I

    change from baseline

    Measured: Day 4, 15, and 29

  8. Single-cell RNASeq

    change from baseline

    Measured: Day 4, 15, and 29

  9. Cardiac death or readmission for heart failure

    • Cardiac death defined as death due to acute MI, sudden cardiac death, HF, stroke, cardiovascular procedure, cardiovascular hemorrhage, or other cardiovascular cause.
    • Heart failure readmission, defined as an event in which the patient is admitted to the hospital with a primary diagnosis of HF, the length of stay is at least 24 hours (or extends over a calendar date), the patient exhibits new or worsening symptoms of HF on presentation, has objective evidence of new or worsening HF, and receives initiation or intensification of treatment specifically for HF.

    Measured: Day 1-90

  10. Left Ventricular Ejection Fraction

    Change from baseline, measured by echocardiography

    Measured: Day 1, Day 90

  11. N-terminal pro B-type natriuretic peptide

    blood test measurement of heart failure

    Measured: Day 90

  12. New York Heart Association Class

    Measurement of cardiac status

    Measured: Day 90

  13. Kansas City Cardiomyopathy Questionnaire

    Patient-reported outcome measure of health status and function

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start6 Feb 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06678074
Sponsor's protocol ID
STEMI01
Status last verified
Mar 2026
First submitted
5 Nov 2024
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Included in publication supplemental materials and provided to central data base

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atibuclimab (IC14), 20 mg/kg intravenously, once in people with STEMI and STEMI (ST Elevation MI), run by Implicit Bioscience at 2 sites in United States.

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 12 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 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 United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (safety and tolerability) (time frame: Day 1-29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06678074.

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 27 Mar 2026.

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