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

NCT07465653 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CHJB647A12103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Sacubitril; Valsartan; Heart failure; Cardiac Failure; Myocardial Failure; Heart failure with reduced ejection fraction

Outcome Measures

Primary Outcomes (2)

• Number of participants with Adverse Events (AEs)

  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

  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 Outcomes (3)

• Pharmacokinetics: Maximum concentration (Cmax)

  Up to 7 days

• Pharmacokinetics: Time to reach maximum plasma concentration (Tmax)

  Up to 7 days

• Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast)

  Up to 7 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Taken by mouth as capsules

Other: Placebo

HJB647 low dose

EXPERIMENTAL

Taken by mouth as capsule

Drug: HJB647 low dose

HJB647 high dose

EXPERIMENTAL

Taken by mouth as capsule

Drug: HJB647 high dose

Interventions

HJB647 low dose DRUG

Study drug low dose in capsule form

HJB647 low dose

HJB647 high dose DRUG

Study drug high dose in capsule form

HJB647 high dose

Placebo OTHER

Placebo control in capsule form

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Synergy Healthcare

Bradenton, Florida, 34208, United States

RECRUITING

Nature Coast Clinical Research LLC

Inverness, Florida, 34452, United States

RECRUITING

Jacksonville Center for Clinical

Jacksonville, Florida, 32216, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)