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Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT06678074•Implicit Bioscience

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. The study treatment patients will be compared to patients who receive placebo (inactive treatment).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG.
•2. TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram
•3. Symptom onset prior to PCI of ≤12 hours
•4. Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI)
•5. Ability to infuse study drug within 12 hours of PCI
•6. Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms)
•7. Capable of completing study visits
•8. Females participating in the study must meet one of the following criteria:
•1. Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year);
•2. Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or
+2 more criteria

Exclusion Criteria

•An individual fulfilling any of the following criteria is to be excluded from enrollment in the study:
•1. Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock)
•2. Severe aortic or mitral valve disease
•3. Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support
•4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
•5. Planned or conducted thrombolytic therapy for treatment of this STEMI event
•6. Planned or conducted coronary artery bypass graft
•7. Previous major vascular intervention within the last 4 weeks
•8. Major surgery within the last 6 weeks
•9. Evidence of an active gastrointestinal or urogenital bleeding
+11 more criteria

Locations (2)

Washington University School of Medicine

St Louis, Missouri, United States

University of Virginia

Charlottesville, Virginia, United States

Key Dates

Start Date

February 6, 2025

Primary Completion Date

March 1, 2026

Completion Date

September 1, 2026

Last Updated

August 20, 2025

Enrollment

ESTIMATED participants

Conditions

STEMISTEMI (ST Elevation MI)STEMI - ST Elevation Myocardial Infarction (MI)Stent Implantation

Interventions

Atibuclimab (IC14), 20 mg/kg intravenously, once

DRUG

Placebo, 150 mL intravenously, once

OTHER

Contacts

Garry Redlich

CONTACT

(303)775-8210 garry.redlich@implicitbioscience.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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