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Clinical Trials in China / NCT06369298
Active, not recruiting Phase 2

Study of JK07 in Patients With Chronic Heart Failure

NCT06369298 · tracked via the Priya Life Science China tracker
Sponsor
Salubris Biotherapeutics Inc
Phase
Phase 2
Started
2024-03-28
Last updated
2026-05-22

Condition(s) studied

Heart Failure With Reduced Ejection FractionHeart Failure With Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

JK07Placebo

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: 0.9% sodium chloride

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

Sex
ALL
Min age
18 Years
Max age
85 Years
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 2 consecutive (duplicate seated) readings at screening. * 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 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 AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-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 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.

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
Site 121 Alexander City Alabama
Site 130 Birmingham Alabama
Site 139 Birmingham Alabama
Site 138 Huntsville Alabama
Site 111 Phoenix Arizona
Site 127 Little Rock Arkansas
Site 128 Huntington Beach California
Site 157 Los Angeles California
Site 158 Orange California
Site 116 Pasadena California
Site 129 Santa Maria California
Site 102 Stanford California
Site 113 Torrance California
Site 133 Vista California
Site 161 Coral Gables Florida
Site 114 Hialeah Florida
Site 162 Miami Lakes Florida
Site 159 Naples Florida
Site 136 Atlanta Georgia
Site 143 Boise Idaho
Site 160 Chicago Illinois
Site 154 Park Ridge Illinois
Site 137 Fort Wayne Indiana
Site 112 Indianapolis Indiana
Site 104 Covington Louisiana
Site 118 Baltimore Maryland
Site 119 Boston Massachusetts
Site 122 Bloomfield Hills Michigan
Site 150 Farmington Hills Michigan
Site 107 Rochester Minnesota
Site 106 St Louis Missouri
Site 105 St Louis Missouri
Site 144 Brick New Jersey
Site 153 Valhalla New York
Site 152 Asheville North Carolina
Site 109 Cary North Carolina
Site 140 Charlotte North Carolina
Site 145 Durham North Carolina
Site 117 Cincinnati Ohio
Site 100 Cleveland Ohio

+ 22 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06369298 on ClinicalTrials.gov ↗ ← All trials in China