This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study to assess the safety, tolerability, immunogenicity, PK, and exploratory efficacy of JK07 in subjects 18 to 80 years of age with HFrEF ≤40%. Initially 5 cohorts are planned with the option to expand the study to a total of 7 cohorts. The size of the cohorts will range from 5 to 9 subjects. Each cohort will include one single active unblinded sentinel subject receiving a single IV dose of JK07 prior to randomized single dose administration of JK07 or placebo \[3:1\] in the remainder of the cohort.
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study to assess the safety, tolerability, immunogenicity, PK, and exploratory efficacy of JK07 in HF subjects 18 to 80 years of age with LVEF ≤40%. Subjects must have been maintained on an optimal HF medical regimen for at least 2 months prior to enrollment and remain on the same treatment regimen throughout the course of the study, per the 2017 ACC/AHA/HFSA) treatment guidelines. At screening, eligible subjects will undergo a physical examination, 2-dimensional transthoracic echocardiography (2D-TTE), ECG assessment, blood sampling for laboratory parameters, and urine testing. Safety assessments at screening will include hematology, biochemistry, coagulation, liver, and thyroid function. Subjects will be observed in the hospital on continuous telemetry from the time of hospital admission until shortly before discharge approximately 48 hours later. During this time, they will additionally have safety labs, vital signs, PK and biomarker samples collected, and ECGs and 2D-TTEs performed. Only a single dose of the investigational product will be administered and only a single hospital admission is planned per subject during the study. Subjects will complete follow-up visits through 180 days after administration of the investigational product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
Vehicle control
University of Arizona College of Medicine
Tucson, Arizona, United States
Stanford University Medical Center
Stanford, California, United States
Harvard Medical School/ Massachusetts General Hospital
Boston, Massachusetts, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health Science University Hospital
Portland, Oregon, United States
University of Texas Southwestern
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Incidence and Severity of Treatment-emergent Adverse Events [Safety and Tolerability]
All safety information is collected and evaluated.
Time frame: Screening to 30 days
AUC(0-last) of JK07
Area under the concentration (time curve to the last quantifiable concentration) from blood samples taken on Days 1-4, and Days 7, 11, 15, 22, 30, and 60.
Time frame: Baseline to 60 days
Cmax of JK07
Maximum concentration from blood samples taken on Days 1-4, and Days 7, 11, 15, 22, 30, and 60.
Time frame: Baseline to 60 days
t1/2 of JK07
Half-life from blood samples taken on Days 1-4, and Days 7, 11, 15, 22, 30, and 60.
Time frame: Baseline to 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.