A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction

Prior treatment

• Acute decompensated heart failure within 3 months prior to screening
• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening
• Hemodynamically significant mitral and/or aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to LV dilation at screening
• Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products

Lab values

• eGFR \<30 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula

Other

• Participants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria:
• SBP \<105 mmHg at screening or baseline.
• BMI \>40 kg/m2
• Women of childbearing potential
  • Further eligibility criteria might apply in alignment with the trial protocol.

• Participants eligible for inclusion in this study must meet all of the following criteria:
• Men and women aged 18 years or older
• Stable NYHA functional class II-III
• LVEF \<50%
• NT-proBNP ≥600 pg/ml if in sinus rhythm or ≥900 pg/ml if in atrial fibrillation at screening
• On stable standard of care therapy with sacubitril/valsartan for at least 4 weeks before screening.