NCT06678074招募中1 期
Phase 1b Pilot Study of Atibuclimab (IC14) for Treatment of ST-Elevation Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Experimental drug intervention
Experimental
monoclonal antibody against CD14
干预措施: Atibuclimab (IC14), 20 mg/kg intravenously, once (Drug)
Placebo
Placebo Comparator
Identical-appearing normal saline for injection, intravenous, once
干预措施: Placebo, 150 mL intravenously, once (Other)
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: Day 1-29
Treatment-emergent adverse events
次要结局
- Single-cell RNASeq(Day 4, 15, and 29)
- CCR2+ cell myocardial infiltration (optional)(48 hours and Day 15)
- Biomarker Interleukin 6(Day 4, 15, and 29)
- Biomarker Interleukin-1(Day 4, 15, and 29)
- 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 Troponin I(Day 4, 15, and 29)
- Cardiac death or readmission for heart failure(Day 1-90)
- Left Ventricular Ejection Fraction(Day 1, Day 90)
- N-terminal pro B-type natriuretic peptide(Day 90)
- New York Heart Association Class(Day 90)
- Kansas City Cardiomyopathy Questionnaire(Day 90)
研究者
研究点 (4)
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