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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат HJB647 low dose
  Study drug low dose in capsule form
• Препарат HJB647 high dose
  Study drug high dose in capsule form
• Другое Placebo
  Placebo control in capsule form

Первичные конечные точки

• Number of participants with Adverse Events (AEs) [Срок оценки: Up to 33 days]
• Number of participants with clinically significant changes in vital signs [Срок оценки: Up to 33 days]

Вторичные конечные точки (3)

• Pharmacokinetics: Maximum concentration (Cmax) [Срок оценки: Up to 7 days]
• Pharmacokinetics: Time to reach maximum plasma concentration (Tmax) [Срок оценки: Up to 7 days]
• Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast) [Срок оценки: Up to 7 days]

Критерии участия

Критерии включения

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 with a dose of at least 49/51 mg BID for at least 4 weeks before screening.

Критерии исключения

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
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Synergy Healthcare — Bradenton
• Nature Coast Clinical Research LLC — Inverness
• Jacksonville Center for Clinical — Jacksonville

Канада · 1 центр

• Novartis Investigative Site — Montreal

Идентификаторы

NCT: NCT07465653 · CHJB647A12103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗