Study of JK07 in Patients With Chronic Heart Failure

Last updated: February 7, 2025
Sponsor: Salubris Biotherapeutics Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Congestive Heart Failure

Hyponatremia

Heart Failure

Treatment

Placebo

JK07

Clinical Study ID

NCT06369298
JK07.2.01
  • Ages 18-85
  • All Genders

Study Summary

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%.

Eligibility Criteria

Inclusion

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%, elevatedN-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrialfibrillation/flutter.

  • Stable heart failure and on optimal medical therapy.

  • Screening hemoglobin ≥ 9.0 g/dL.

Exclusion

Exclusion Criteria:

  • Uncontrolled hypertension.

  • Sustained systolic Blood Pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg on 2consecutive (duplicate seated) readings at screening.

  • Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrativecardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonansyndrome with LV hypertrophy or a positive serum immunofixation result.

  • Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartumcardiomyopathy.

  • Diagnosis of chemotherapy- or radiation-induced cardiomyopathy.

  • Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks ofscreening.

  • History of syncope within the last 12 weeks prior to screening or sustainedventricular tachycardia without an implantable cardioverter-defibrillator.

  • Moderate or severe aortic and/or mitral valve stenosis.

  • Medically documented unstable angina, acute coronary syndrome (e.g., myocardialinfarction, troponin-positive with symptoms of angina or unstable angina) within thelast 8 weeks prior to start of screening.

  • Medically documented ST-elevation myocardial infarction within 12 weeks ofscreening.

  • Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with aresting ventricular rate > 110 beats per minute at screening.

  • For participants with a history of AF or atrial flutter, not on adequateanticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if theCHA2DS2-VASc score is ≥ 2 in men or ≥ 3 in women or per local guidelines.Percutaneous occlusion of the left atrial appendage alone is not adequate.

  • AF ablation within the last 12 weeks prior to screening or planned during the studyduration.

  • Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart blockwithout a pacemaker.

  • Cardiac surgery, coronary artery revascularization or indication for coronary arteryrevascularization, percutaneous coronary intervention, valve repair/replacement orvalvuloplasty within 12 weeks prior to screening.

  • Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeksprior to screening, or intent to implant a CRT device during the course of thestudy.

  • Previous cardiac transplantation, or any use of mechanical circulatory support orsimilar device, or implantation expected after randomization.

  • Receiving mechanical hemodynamic support or invasive mechanical ventilation withinthe last 8 weeks prior to screening.

  • Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeksprior to screening.

  • Receiving IV vasodilators within the last 4 weeks prior to screening.

  • Receiving noninvasive mechanical ventilation within the last 4 weeks prior toscreening. The use of noninvasive ventilation for sleep disordered breathing ispermitted.

Study Design

Total Participants: 282
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 28, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Site 202

    Winnepeg, Manitoba R2H2A6
    Canada

    Active - Recruiting

  • Site 203

    Brampton, Ontario L6Z 4N5
    Canada

    Active - Recruiting

  • Ecogene-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Active - Recruiting

  • Site 200

    Chicoutimi, Quebec G7H 7K9
    Canada

    Active - Recruiting

  • Site 201

    Trois-Rivieres, Quebec G9A 4P3
    Canada

    Active - Recruiting

  • Site 305

    Changsha, Hunan 410005
    China

    Active - Recruiting

  • Site 303

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

  • Site 306

    Jining, Shandong 272100
    China

    Active - Recruiting

  • Site 301

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Site 300

    Beijing, 100037
    China

    Active - Recruiting

  • Site 304

    Chongqing, 404000
    China

    Active - Recruiting

  • Site 156

    Ponce, 00717
    Puerto Rico

    Active - Recruiting

  • Advanced Cardiovascular LLC

    Alexander City, Alabama 35010
    United States

    Active - Recruiting

  • Site 121

    Alexander City, Alabama 35010
    United States

    Active - Recruiting

  • Site 130

    Birmingham, Alabama 35211
    United States

    Active - Recruiting

  • Site 139

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Site 138

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Site 111

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Site 127

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • National Institute of Clinical Research

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Site 128

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Site 158

    Orange, California 92868
    United States

    Active - Recruiting

  • Site 116

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Southern California Heart Specialists

    Pasadena, California 91105
    United States

    Active - Recruiting

  • FOMAT Medical Research

    Santa Maria, California 93454
    United States

    Active - Recruiting

  • Site 129

    Santa Maria, California 93454
    United States

    Active - Recruiting

  • Site 102

    Stanford, California 94305
    United States

    Active - Recruiting

  • Site 113

    Torrance, California 90502
    United States

    Active - Recruiting

  • Blue Coast Research Center, LLC

    Vista, California 92081
    United States

    Active - Recruiting

  • Site 133

    Vista, California 92081
    United States

    Active - Recruiting

  • New Generation of Medical Research

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Site 114

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Site 159

    Naples, Florida 34104
    United States

    Active - Recruiting

  • Accel Research Sites

    Atlanta, Georgia 30343
    United States

    Active - Recruiting

  • Site 136

    Atlanta, Georgia 30343
    United States

    Active - Recruiting

  • Site 143

    Boise, Idaho 83712
    United States

    Active - Recruiting

  • Site 160

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Site 154

    Park Ridge, Illinois 60068
    United States

    Active - Recruiting

  • Nexgen Research

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Site 137

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Community Health Network

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Site 112

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Louisiana Heart Center

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Site 104

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Site 119

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Cardiology and Vascular Associates

    Bloomfield Hills, Michigan 48304
    United States

    Active - Recruiting

  • Profound Research LLC/Cardiology and Vascular Associates - CAVA

    Bloomfield Hills, Michigan 48304
    United States

    Active - Recruiting

  • Site 122

    Bloomfield Hills, Michigan 48304
    United States

    Active - Recruiting

  • Pulse Cardiology

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Site 150

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Site 107

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Site 105

    Saint Louis, Missouri 63136
    United States

    Active - Recruiting

  • Site 106

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • St. Louis Heart and Vascular Cardiology

    Saint Louis, Missouri 63136
    United States

    Active - Recruiting

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Ash Research Clinic

    Brick, New Jersey 08724
    United States

    Active - Recruiting

  • Site 144

    Brick, New Jersey 08724
    United States

    Active - Recruiting

  • Site 153

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Site 152

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Cary Research Group, LLC

    Cary, North Carolina 27518
    United States

    Active - Recruiting

  • Site 109

    Cary, North Carolina 27518
    United States

    Active - Recruiting

  • Site 140

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Site 117

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Site 100

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Site 135

    Oklahoma City, Oklahoma 73135
    United States

    Active - Recruiting

  • Site 155

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Site 110

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Site 115

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Southwest Family Medicine

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Site 103

    Houston, Texas 77030
    United States

    Active - Recruiting

  • LinQ Research, LLC

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Site 149

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Site 148

    Arlington, Virginia 22205
    United States

    Active - Recruiting

  • Site 123

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Site 126

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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