A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Start Date
3/18/2026
Completion Date
9/24/2026
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).
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.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
HJB647 low dose
HJB647 high dose
Placebo
Conditions
Locations
Synergy Healthcare
Bradenton, Florida 34208
United States
Nature Coast Clinical Research LLC
Inverness, Florida 34452
United States
Jacksonville Center for Clinical
Jacksonville, Florida 32216
United States
Novartis Investigative Site
Montreal, Quebec H1T 1C8
Canada