Last Update: Jul 08, 2026 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 ClinicalTrials.gov Identifier: [NCT07465653](https://clinicaltrials.gov/ct2/show/NCT07465653) Novartis Reference Number:CHJB647A12103 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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). This is 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 or mildly reduced ejection fraction (HFrEF/HFmrEF). The study will consist of approximately 12 participants randomly assigned in a 1:1:1 ratio to one of three 3-day treatment sequences comprised of two doses of HJB647 and placebo. Dosing of the HJB647 and placebo is planned for 3 consecutive days. Participants will be domiciled during study drug administration period for close monitoring with a follow-up in-clinic visit on Day 7. A safety call will be performed on Day 33. Condition Heart Failure With Reduced Ejection Fraction Phase Phase1 Overall Status Recruiting Number of Participants12 Start Date Mar 18, 2026 Completion Date Sep 24, 2026 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### HJB647 high dose Study drug high dose in capsule form Drug ### HJB647 low dose Study drug low dose in capsule form Other ### Placebo Placebo control in capsule form ## 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 with a dose of at least 49/51 mg BID 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. Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H1t 1c8,Canada United States #### Synergy Healthcare Recruiting Bradenton,Florida,34208,United States ###### Patrick Weston ###### Shannon Stickels Email: #### Nature Coast Clinical Research LLC Recruiting Inverness,Florida,34452,United States ###### Jill Barnett Phone: [+1 352 341 2100]() Email: ###### Rafik Abadier #### Jacksonville Center for Clinical Recruiting Jacksonville,Florida,32216,United States ###### Michael J Koren ###### Sara Villotti Phone: [+1 904 730 0101]() Email: ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: