Actively Recruiting
A Multi-center, Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Safety, Tolerability, and Pharmacokinetics of HJB647 in Adults With Chronic Stable Heart Failure With Reduced or Mildly Reduced Ejection Fraction
Led by Novartis Pharmaceuticals · Updated on 2026-04-15
12
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of the drug HJB647 at two different doses in adults with chronic stable heart failure who have reduced or mildly reduced ejection fraction (HFrEF/HFmrEF). This Phase 1 study is designed as a multi-center, randomized, double-blind, placebo-controlled crossover trial to carefully assess these aspects in this specific heart condition. Participants will be randomly assigned to one of three treatment sequences for three consecutive days, receiving either a low dose of HJB647, a high dose of HJB647, or a placebo. The study drug and placebo are taken orally as capsules. Participants will stay at the study site during dosing for close monitoring, followed by a clinic visit on Day 7 and a safety phone call on Day 33 to track their health. During the study, researchers will monitor adverse events and significant changes in vital signs over 33 days. They will also measure how the body absorbs and processes HJB647, including drug concentration levels and timing up to 7 days after dosing. This careful follow-up aims to ensure participant safety and gather important information about the drug's behavior in the body throughout the trial period.
CONDITIONS
Brief Title
A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Stable NYHA functional class II-III heart failure
- Left ventricular ejection fraction less than 50%
- NT-proBNP at least 600 pg/ml if in sinus rhythm or at least 900 pg/ml if in atrial fibrillation at screening
- On stable standard care with sacubitril/valsartan at a dose of at least 49/51 mg twice daily for at least 4 weeks before screening
You will not qualify if you...
- Acute decompensated heart failure within 3 months before screening
- Systolic blood pressure less than 105 mmHg at screening or baseline
- Recent acute coronary syndrome, stroke, transient ischemic attack, major cardiovascular surgery, PCI, or carotid angioplasty within 6 months prior to screening
- Significant mitral and/or aortic valve disease or prior valve replacement except mitral regurgitation secondary to left ventricular dilation at screening
- Estimated glomerular filtration rate less than 45 ml/min/1.73m2 at screening
- Body mass index over 40 kg/m2
- Use of strong CYP3A4 inhibitors or inducers, sGC activators, PDE5 inhibitors, or nitroglycerin products
- Women of childbearing potential
- Other criteria as per trial protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive two doses of HJB647 or placebo over 3 consecutive days while domiciled for close monitoring.
Domiciled during dosing period with daily monitoring visits
Duration - Up to 33 days post-treatment
Participants attend an in-clinic visit on Day 7 and receive a safety phone call on Day 33 to monitor safety and tolerability.
1 in-clinic follow-up visit and 1 safety phone call
Trial Site Locations
Total: 3 locations
1
Synergy Healthcare
Bradenton, Florida, United States, 34208
Actively Recruiting
2
Nature Coast Clinical Research LLC
Inverness, Florida, United States, 34452
Actively Recruiting
3
Jacksonville Center for Clinical
Jacksonville, Florida, United States, 32216
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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