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

NCT06678074 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: STEMI01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

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

Keywords

atibuclimab; IC14; monoclonal antibody against CD14; anti-CD14; antiinflammatory

Outcome Measures

Primary Outcomes (1)

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

  Treatment-emergent adverse events

  Day 1-29

Secondary Outcomes (13)

• CCR2+ cell myocardial infiltration (optional)

  48 hours and Day 15

• Biomarker C-Reactive Protein

  Day 4, 15, 29

• Biomarker White Blood Cell Count

  Day 4, 15, and 29

• Biomarker Fibrinogen

  Day 4, 15, 29

• Biomarker Interleukin 6

  Day 4, 15, and 29

Other Outcomes (3)

• Pharmacokinetic profile of serum IC14 level, including serum half life and maximum serum concentration

  baseline, 15 minutes, 6 hours, Day 4, Day 15, Day 22, Day 29

• Pharmacodynamics

  Day 22, Day 29

• Immunogenicity

  baseline, Day 29, Day 90

Study Arms (2)

Experimental drug intervention

EXPERIMENTAL

monoclonal antibody against CD14

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

Placebo

PLACEBO COMPARATOR

Identical-appearing normal saline for injection, intravenous, once

Other: Placebo, 150 mL intravenously, once

Interventions

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

monoclonal antibody against CD14

Experimental drug intervention

Placebo, 150 mL intravenously, once OTHER

sterile normal saline for injection

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Implicit Bioscience: lead
• Washington University School of Medicine: collaborator
• University of Virginia: collaborator

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Virginia

Charlottesville, Virginia, 22908-1394, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

atibuclimab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Marc Sintek, MD

  PI

  PRINCIPAL INVESTIGATOR

• Antonio Abbate, MD, PhD

  PI

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: study completion
• Access Criteria: public access through journal website and/or ClinicalTrials.gov website listing

Locations

US (2)