Study of HJB647 Safety and How It Acts in Adults With Stable Chronic Heart Failure and Reduced Ejection Fraction

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of the drug HJB647 in people with chronic stable heart failure who have reduced or mildly reduced ejection fraction HFrEFHFmrEF. This Phase 1 trial is designed as a multi-center, randomized, participant- and investigator-blinded, placebo-controlled crossover study to better understand how two different doses of HJB647 affect these participants. The study includes participants with stable heart failure under standard care with sacubitrilvalsartan therapy. Participants are randomly assigned to one of three treatment sequences, each lasting 3 days, which include two different doses of HJB647 and a placebo, all given as capsules by mouth. During the dosing period, participants stay in a controlled setting for close monitoring. Following the dosing, there is an in-clinic follow-up visit on Day 7 and a safety phone call on Day 33 to monitor any adverse events or vital sign changes. Throughout the study, participants undergo monitoring to track adverse events and changes in vital signs up to 33 days. Pharmacokinetic measurements such as maximum drug concentration, time to reach maximum concentration, and area under the concentration-time curve are collected up to 7 days. The study lasts approximately one month, including dosing, follow-up visits, and safety assessments to evaluate the drugs behavior and tolerability in this patient group.

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