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RecruitingPhase 1

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

A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of HJB647 in Participants With Chronic Stable Heart Failure With Reduced Ejection Fraction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two doses of HJB647 in adults with stable, long-term heart failure whose hearts pump less blood than normal. It looks at safety, side effects, and how the body handles the drug.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Stable heart failure with symptoms during regular or light activity (NYHA class II–III).
  • The heart pumps out less than 50% of the blood in its main pumping chamber with each beat (LVEF).
  • A blood marker linked to heart failure (NT-proBNP) is at least 600 pg/ml with a normal heart rhythm, or at least 900 pg/ml with atrial fibrillation, an irregular heart rhythm.
  • On stable usual heart failure treatment that includes sacubitril/valsartan for at least 4 weeks before screening.

Who can't join

  • Sudden worsening of heart failure in the 3 months before screening.
  • Top blood pressure number below 105 mmHg at screening or the starting visit.
  • In the past 6 months: a heart attack or other sudden loss of blood flow to the heart, stroke, mini-stroke, major heart or blood vessel surgery, or a procedure to open heart or neck arteries.
  • Serious mitral or aortic heart valve disease that affects blood flow, or any past valve replacement. A leaking mitral valve caused by an enlarged main pumping chamber is an exception.
  • Kidney filtering test result (eGFR) below 30 ml/min/1.73m² at screening.
  • Body mass index (BMI), a measure based on height and weight, above 40 kg/m².
  • Use of drugs that strongly affect the CYP3A4 enzyme, which helps process medicines; sGC drugs such as vericiguat; PDE5 inhibitors; or nitroglycerin products.
  • Women who could become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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. Exclusion Criteria: Participants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria: * Acute decompensated heart failure within 3 months prior to screening * SBP \<105 mmHg at screening or baseline. * 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 * eGFR \<30 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula * BMI \>40 kg/m2 * Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products * Women of childbearing potential Further eligibility criteria might apply in alignment with the trial protocol.

Study sites (5)

FL