Heart Failure With Reduced Ejection FractionPhase 1NCT07465653
A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
A Phase 1 study testing HJB647 low dose and HJB647 high dose in people with Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- HJB647 low dose and HJB647 high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Mar 2026to 8 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
6 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Synergy Healthcare
Bradenton, Florida, 34208
Shannon Stickels, sstickels@synergyhealthcorp.com
Patrick Weston
- Recruiting
Nature Coast Clinical Research LLC
Inverness, Florida, 34452
Jill Barnett, +1 352 341 2100, jbarnett@flourishresearch.com
Rafik Abadier
- Recruiting
Jacksonville Center for Clinical
Jacksonville, Florida, 32216
Sara Villotti, +1 904 730 0101, svillotti@flourishresearch.com
Michael J Koren
- Recruiting
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
Lazaro Rivero, +1 786 502 4303, lrivero@inpatientresearch.com
Alexis Gutierrez
- Recruiting
Flourish Research
Winter Park, Florida, 32789
Sara Contreras, scontreras@flourishresearch.com
Monica Aggarwal
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H1T 1C8
About this study
Official title: 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).
Read the 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.
- Being tested
- HJB647 low dose, HJB647 high dose, Placebo
- Keywords
- Sacubitril, Valsartan, Heart failure, Cardiac Failure, Myocardial Failure, Heart failure with reduced ejection fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HJB647 low doseDrug
Study drug low dose in capsule form
HJB647 high doseDrug
Study drug high dose in capsule form
PlaceboOther
Placebo control in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Taken by mouth as capsules Receives: Other: Placebo |
| HJB647 low dose | Experimental | Taken by mouth as capsule Receives: Drug: HJB647 low dose |
| HJB647 high dose | Experimental | Taken by mouth as capsule Receives: Drug: HJB647 high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Number of participants with AEs as a measure of safety and tolerability
Measured: Up to 33 days
Number of participants with clinically significant changes in vital signs
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
Measured: Up to 33 days
Secondary outcomes (3)
Pharmacokinetics: Maximum concentration (Cmax)
Maximum concentration (Cmax) of the trial drug in participants' blood
Measured: Up to 7 days
Pharmacokinetics: Time to reach maximum plasma concentration (Tmax)
Time to require the trial drug to reach its maximum concentration in participants blood
Measured: Up to 7 days
Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast)
Area under the curve from time zero to the last measurable concentration sampling time
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start18 Mar 2026
- Primary completion8 Dec 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465653
- Sponsor's protocol ID
- CHJB647A12103
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT07465653
- Acronym / sponsor ID
- CHJB647A12103
- Keywords
- Sacubitril, Valsartan, Heart failure, Cardiac Failure, Myocardial Failure, Heart failure with reduced ejection fraction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 8 Dec 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboTaken by mouth as capsules |
| HJB647 low dose | Experimental | Drug: HJB647 low doseTaken by mouth as capsule |
| HJB647 high dose | Experimental | Drug: HJB647 high doseTaken by mouth as capsule |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HJB647 low doseStudy drug low dose in capsule form | Drug | HJB647 low dose |
| HJB647 high doseStudy drug high dose in capsule form | Drug | HJB647 high dose |
| PlaceboPlacebo control in capsule form | Other | Placebo |
Primary outcome
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
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
3 secondary outcomes
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Up to 7 days
Pharmacokinetics: Time to reach maximum plasma concentration (Tmax)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HJB647 low dose and HJB647 high dose in people with Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: Up to 33 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.