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

April 10, 2026 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34208
      • Inverness, Florida, United States, 34452
        • Recruiting
        • Nature Coast Clinical Research LLC
        • Principal Investigator:
          • Rafik Abadier
        • Contact:
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical
        • Principal Investigator:
          • Michael J Koren
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 <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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Taken by mouth as capsules
Other: Placebo
Placebo control in capsule form
Experimental: HJB647 low dose
Taken by mouth as capsule
Drug: HJB647 low dose
Study drug low dose in capsule form
Experimental: HJB647 high dose
Taken by mouth as capsule
Drug: HJB647 high dose
Study drug high dose in capsule form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: Up to 33 days
Number of participants with AEs as a measure of safety and tolerability
Up to 33 days
Number of participants with clinically significant changes in vital signs
Time Frame: Up to 33 days
Number of participants with clinically significant changes in Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Electrocardiogram and hyposensitive events as a measure of adverse events
Up to 33 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Maximum concentration (Cmax)
Time Frame: Up to 7 days
Maximum concentration (Cmax) of the trial drug in participants' blood
Up to 7 days
Pharmacokinetics: Time to reach maximum plasma concentration (Tmax)
Time Frame: Up to 7 days
Time to require the trial drug to reach its maximum concentration in participants blood
Up to 7 days
Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast)
Time Frame: Up to 7 days
Area under the curve from time zero to the last measurable concentration sampling time
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

September 24, 2026

Study Completion (Estimated)

September 24, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHJB647A12103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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