Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)

  • STATUS
    Recruiting
  • End date
    Mar 15, 2022
  • participants needed
    63
  • sponsor
    Salubris Biotherapeutics Inc
Updated on 23 February 2021

Summary

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.

Description

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 3 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.

Details
Condition Heart Failure With Reduced Ejection Fraction
Treatment Matching Placebo, JK07
Clinical Study IdentifierNCT04210375
SponsorSalubris Biotherapeutics Inc
Last Modified on23 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults 18 and 80 years with stable NYHA Class II or III HF diagnosis (ischemic or non-ischemic confirmed by medical history) at least 6 months prior to enrollment as confirmed by medical history
Stable HF defined as no hospitalizations for cardiac-related issues within the previous 3 months prior to the screening visit or between screening and randomization, other than for routine device generator changes
Subjects with clearly interpretable echocardiographic images and with a screening LVEF 40% in the absence of Grade 3 valvular disease on 2D-TTE
Subjects must be taking clinician-directed appropriate pharmacological therapy for HF as per the 2017 ACC/AHA/HFSA treatment guidelines at stable doses (except for diuretics) for at least 3 months prior to screening. Subjects with implantable cardioverter-defibrillators (ICDs), if the devices are not "pacing", are eligible
Body mass index 18 kg/m2 and 40 kg/m2
Screening hemoglobin 9.0 g/dL, platelets 100 K/mL, ANC 1500/mL
Able and willing to use adequate contraception until the end of the study
Capable of providing informed consent and to comply with the protocol

Exclusion Criteria

Participating in any other study, have received any other investigational drug within 30 days prior to screening or 5-half-lives or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments
Any past participation in a study that has investigated the NRG-1 pathway (e.g., Neucardin, Cimaglermin)
Heart failure due to hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricula dysplasia (ARVD), stress-induced ("Takotsubo") cardiomyopathy, chemotherapy-induced cardiomyopathy, peripartum cardiomyopathy, infiltrative or inflammatory cardiomyopathies, and primary valvular disease
Acute coronary syndrome within 3 months of screening or acute MI within 6 months of screening
Cardiac surgery, coronary artery revascularization, percutaneous coronary intervention, or valvuloplasty within 3 months prior to screening
Any subject who has received an indication for coronary revascularization within 3 months prior to screening
Any major surgical procedure within 1 month prior to screening or planned surgical procedure during the study period
Sustained systolic blood pressure <100 mm Hg and/or diastolic blood pressure <50 mm Hg
Sustained resting heart rate >100 beats per minute
Cerebrovascular accident or hospitalizations for CV (cardiovascular) causes other than routine device generator changes, including HF, chest pain, stroke, transient ischemic attack, or arrhythmias within 3 months prior to randomization
At screening have an abnormal or clinically significant 12-lead ECG abnormality, ei.; (QRS >120 msec, PR >210 msec, heart rate (HR) <45 bpm, sustained HR >100 bpm) that, in the opinion of the Investigator, would affect efficacy or safety evaluation or place the subject at risk
History or evidence of clinically significant arrhythmia uncontrolled by drug therapy or use of an implantable defibrillator, long QT syndrome, or evidence of QT prolongation with QTcF >450 ms for males or QTcF >470 ms for females prior to randomization
Clinically significant renal dysfunction as measured by the estimated GFR <45 mL/min/1.73m2 at screening, or a clinically significant change in renal function between screening and baseline
Clinically significant liver dysfunction as measured by: ALT >2.0 ULN, alkaline phosphatase > 2.0 ULN, AST >2.0 the ULN, or GGT >2.0 the ULN or serum bilirubin 1.2 the ULN at screening, or a clinically significant change in liver function between screening and baseline
Subjects with alteration of the coagulation panel (INR) and/or PT 1.5 the ULN; aPTT 1.5 ULN, or serum albumin 3 gm/dL. For subjects on warfarin or other anticoagulants, an INR (or PT/PTT) considered by the Principal Investigator as therapeutically appropriate will be allowed
Subjects with values of CPK and/or CK-MB >2.5 times normal institutional limits at screening
Any subject who by Investigator's judgement, has a significant hematuria or proteinuria at screening
Concurrent treatment with Class I or III antiarrhythmic drugs (unless the medication was discontinued more than 3 months before proposed enrollment)
Positive screening for HIV antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies
Known history of or active alcohol abuse (no more than 14 units/week for males or 7 units/week for females) or use of illicit drugs within 1 year prior to randomization other than recreational use of marijuana or cannabis-based products
Other medical or psychiatric condition that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the secondary objectives of study
A history of malignancy of any type or any pre-malignant condition (e.g. ductal carcinoma in situ, colonic polyp, or cervical atypia). All subjects are to undergo cancer screening following study enrollment in accordance with American Cancer Society Guidelines
Pregnant or lactating female subjects at screening
Subjects with clinically significant or poorly controlled disease including, but not limited to, endocrine (including diabetes and thyroid) disease, neurological or psychiatric (even mild), GI, hematological, urological, immunological, or ophthalmic diseases as determined by the Investigator
Subjects who are not non-smokers or light smokers (no more than 5 cigarettes per day) and who cannot abstain from smoking from 2 weeks prior to the administration of IP through the end of the study
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