A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety and Tolerability of JK07 in Subjects With Heart Failure With Preserved Ejection Fraction (HFpEF)
A phase 1, randomized, double-blind, placebo-controlled single-ascending dose study to assess JK07 in adult subjects with heart failure with preserved ejection fraction.
• Stable New Yok Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrollment as confirmed by medical history.
• Documented prior objective evidence of heart failure as shown by 1 or more of the following criteria:
∙ Previous hospitalization for heart failure with documented radiographic evidence of pulmonary congestion.
‣ Elevated left ventricular (LV) end-diastolic pressure or pulmonary capillary wedge pressure at rest (≥15 mm Hg) or with exercise (≥25 mm Hg).
‣ Elevated level of NT-proBNP (\>400 pg/mL) or brain natriuretic peptide (BNP) (\>200 pg/mL).
‣ Echocardiographic evidence of medial E/e' ratio ≥ 15 or Left Atrial Volume (LAV) \>58 mL in male patients or \>52 mL in female patients.
• Adequate acoustic windows on screening resting TTE
• Documented structural abnormality consistent with HFpEF confirmed at the screening visit by clearly interpretable echocardiography assessment.
• Meets 1 or more of the following criteria at the initial screening measurement:
∙ A hs-cTnI \>99th percentile
‣ NT-proBNP \>300 pg/mL (if not in atrial fibrillation or atrial flutter) or \>600 pg/mL (if in atrial fibrillation or atrial flutter), or if the screened participant is either of African descent or has a body mass index ≥30.0 kg/m2, a screening NT-proBNP \>240 pg/mL (if not in atrial fibrillation or atrial flutter) or \>480 pg/mL (if in atrial fibrillation or atrial flutter).
• Body mass index (BMI) ≥18 kg/m2 and ≤45 kg/m2
• Screening hemoglobin ≥9.0 g/dL, platelets ≥100x109 /mL, absolute neutrophil count (ANC) ≥1500/mL.
• Sexually mature biological male subjects must agree to use a medically accepted method of contraception throughout the study and be willing and able to continue contraception until the end of the study (6-month time point).
• Biological females of childbearing potential must present with a negative blood pregnancy test, must not be lactating, and must agree to employ adequate birth control measures for the duration of the study and be willing and able to continue contraception until the end of the study (6-month time point).
⁃ Subject is capable of giving signed informed consent.
⁃ Subject is willing and able to comply with the requirements of the protocol.