Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Redu… (NCT05328752) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
United States, Netherlands27 participantsStarted 2022-05-17
Plain-language summary
This is a multi-center, randomized, sponsor open-label, participant- and investigator-blinded, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in HFrEF/HFmrEF.
Who can participate
Age range18 Years – 80 Years
SexALL
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Key Inclusion Criteria:
* NYHA functional class II-III
* LVEF ≤ 50% documented at screening
* Systolic blood pressure 110 - 160 mmHg (cohort 1) or 105-160 mmHg (cohort 2), and heart rate between 50-90 beats per minute, inclusive
* Treatment with a stable dose of a beta blocker.
* Cohort 1: Treatment with a stable dose of ACE inhibitor or ARB
* Cohort 2: Treatment with a stable dose of sacubitril/valsartan.
Key Exclusion Criteria
* Acute decompensated heart failure within 3 months prior to screening. 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, except mitral regurgitation secondary to LV dilatation at screening
* Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period
* History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening
* eGFR \<45 mL/min/1.73 m2 at screening
* Cohort 1 only: Treatment with sacubitril/valsartan currently or within 4 weeks from screening
* Cohort 2: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening
* BMI \>40 kg/m2
Other protocol-specific criteria may apply.
What they're measuring
1
Adverse events, which may include abnormal vital signs, safety lab tests, or ECG parameters that induce clinical signs or symptoms, are considered clinically significant or require therapy
Timeframe: 91 days (Cohort 1), 146 days (Cohort 2)