Study of JK07 in Patients With Chronic Heart Failure

Purpose

This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. There will be 2 cohorts in this study: Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%. Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) > 40% and ≤ 65%. Participants in both cohorts will be randomized into either low dose JK07, high dose JK07 or placebo. Participants will have a 2:1 chance of receiving JK07 versus placebo.

Conditions

  • Heart Failure With Reduced Ejection Fraction
  • Heart Failure With Preserved Ejection Fraction

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with New York Heart Association (NYHA) Class II-III. - Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%. - Cohort 2 - Left Ventricular Ejection Fraction (LVEF) >40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter. - Stable heart failure and on optimal medical therapy. - Screening hemoglobin ≥ 9.0 g/dL.

Exclusion Criteria

  • Uncontrolled hypertension. - Sustained systolic Blood Pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg on at least 3 consecutive readings. - Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result. - Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy. - Diagnosis of chemotherapy- or radiation-induced cardiomyopathy. - Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening. - History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator. - Moderate or severe aortic and/or mitral valve stenosis. - Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks prior to start of screening. - Medically documented ST-elevation myocardial infarction within 12 weeks of screening. - Any narrow complex tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate > 110 beats per minute at screening. - For participants with a history of Atrial Fibrillation (AF) or atrial flutter, and a CHA2DS2-VASc score of ≥ 2 in men or ≥ 3 in women or per local guidelines, anticoagulation via non-vitamin K oral anticoagulants or warfarin is required. Percutaneous occlusion of the left atrial appendage alone is not adequate. - AF ablation within the last 12 weeks or planned during the study duration. - Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker. - Cardiac surgery, coronary artery revascularization or indication for coronary artery revascularization, percutaneous coronary intervention, valve repair/replacement or valvuloplasty within 12 weeks prior to screening. - Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeks prior to screening, or intent to implant a CRT device during the course of the study. - Previous cardiac transplantation, or any use of mechanical circulatory support or similar device, or implantation expected after randomization. - Receiving mechanical hemodynamic support or invasive mechanical ventilation within the last 8 weeks prior to screening. - Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeks prior to screening. - Receiving IV vasodilators within the last 4 weeks prior to screening. - Receiving noninvasive mechanical ventilation within the last 4 weeks prior to screening. The use of noninvasive ventilation for sleep disordered breathing is permitted.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
JK07 low dose 		JK07 administered by intravenous (IV) infusion
  • Drug: JK07
    JK07 is a fully human anti-human epidermal growth factor receptor 3 (also known as ErbB3 or HER3) antibody fused with the epidermal growth factor (EGF)-domain of Neuregulin (NRG)-1b protein.
Active Comparator
JK07 high dose 		JK07 administered by intravenous (IV) infusion
  • Drug: JK07
    JK07 is a fully human anti-human epidermal growth factor receptor 3 (also known as ErbB3 or HER3) antibody fused with the epidermal growth factor (EGF)-domain of Neuregulin (NRG)-1b protein.
Placebo Comparator
Placebo 		Placebo administered by intravenous (IV) infusion
  • Drug: Placebo
    0.9% sodium chloride

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Greg Lewis

More Details

Status
Recruiting
Sponsor
Salubris Biotherapeutics Inc

Study Contact

Amanda McEwen
888-521-8961
Info@SalubrisBio.com