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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Study drug low dose in capsule form
Study drug high dose in capsule form
Placebo control in capsule form
Synergy Healthcare
Bradenton, Florida, United States
RECRUITINGNature Coast Clinical Research LLC
Inverness, Florida, United States
RECRUITINGJacksonville Center for Clinical
Jacksonville, Florida, United States
RECRUITINGNumber of participants with Adverse Events (AEs)
Number of participants with AEs as a measure of safety and tolerability
Time frame: 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
Time frame: Up to 33 days
Pharmacokinetics: Maximum concentration (Cmax)
Maximum concentration (Cmax) of the trial drug in participants' blood
Time frame: 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
Time frame: 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
Time frame: Up to 7 days
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