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
Novartis Pharmaceuticals
12 participants
Mar 18, 2026
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria6
- 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 with a dose of at least 49/51 mg BID for at least 4 weeks before screening.
Exclusion Criteria9
- 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 <45 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.
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Interventions
Study drug low dose in capsule form
Study drug high dose in capsule form
Placebo control in capsule form
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07465653