Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Salubris Biotherapeutics Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: JK07
  • Drug: Matching Placebo

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   1. 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.

   2. Stable HF defined as no hospitalizations for cardiac-related issues within the
   previous 2 months prior to the screening visit or between screening and randomization,
   other than for routine percutaneous procedures such as device, battery, generator
   changes or pacemaker lead insertion/ replacement.

   3. Subjects with clearly interpretable echocardiographic images and with a screening LVEF
   ≤ 40% in the absence of ≥ Grade 3 valvular disease on 2D-TTE.

   4. Subjects must be taking clinician-directed appropriate pharmacological therapy for HF
   as per the 2017 ACC/AHA/HFSA treatment guidelines at stable doses and at investigator
   determined discretion (except for diuretics) for at least 2 months prior to informed
   consent.

   5. Subjects with implantable cardioverter-defibrillators (ICDs) are allowed at the
   discretion of the investigator, but only if both the following criteria are met: (a)
   paced beats cannot exceed 15% of beats as quantified by screening e-Patch, and (b) if
   a non-paced baseline ECG can be obtained on day 1 prior to study drug administration.

5. Body mass index ≥18 kg/m2 and ≤45 kg/m2. 6. Screening hemoglobin ≥9.0 g/dL, platelets
≥100 K/mL, ANC ≥1500/mL. 7. Able and willing to use adequate contraception until the end of
the study.

8. Capable of providing informed consent and to comply with the protocol.

Exclusion Criteria:

   1. 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.

   2. Any past participation in a study that has investigated the NRG-1 pathway (e.g.,
   Neucardin, Cimaglermin).

   3. 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.

   4. Medically documented acute coronary syndrome within 3 months of screening or a
   medically documented acute MI within 6 months of screening.

   5. Cardiac surgery, coronary artery revascularization, percutaneous coronary
   intervention, or valvuloplasty within 3 months prior to screening.

   6. Any subject who has received an indication for coronary revascularization within 3
   months prior to screening.

   7. Any major surgical procedure within 1 month prior to screening or planned surgical
   procedure during the study period.

   8. Sustained systolic blood pressure <90 mm Hg and/or diastolic blood pressure <50 mm Hg.

   9. Sustained resting heart rate >100 beats per minute sustained for >15 minutes except in
   sustained atrial fibrillation when a heart rate of up to 110 beats per minute is
   acceptable.

10. Cerebrovascular accident or hospitalizations for CV (cardiovascular) causes other than
   routine percutaneous procedures such as device, battery, generator changes or
   pacemaker lead insertion/ replacement or device generator changes, including HF, chest
   pain, stroke, transient ischemic attack, or arrhythmias within 3 months prior to
   randomization.

11. At screening have an abnormal or clinically significant 12-lead ECG abnormality that,
   in the opinion of the Investigator, would affect efficacy or safety evaluation or
   place the subject at risk.

12. 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.

13. 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.

14. 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.

15. 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) considered by the Principal Investigator as
   therapeutically appropriate will be allowed.

16. Subjects with values of CPK and/or CK-MB >2.5 times normal institutional limits at
   screening.

17. Any subject who by Investigator's judgement, has a significant hematuria or
   proteinuria at screening.

18. Concurrent treatment with Class Ia or III antiarrhythmic drugs (the medication must
   have been discontinued more than 2 months before informed consent).

19. Positive screening for HIV antibodies, hepatitis B surface antigen, or hepatitis C
   virus antibodies.

20. 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
   (excluding recreational use of marijuana or cannabidiol [CBD]-based products.

21. 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.

22. A history of pathologically-confirmed malignancy of any type or any
   pathologically-confirmed pre-malignant condition (e.g. ductal carcinoma in situ,
   colonic polyp with premalignant diagnosis, or cervical atypia).

23. Pregnant or lactating female subjects at screening.

24. 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.

25. 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.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicole Howard
6507256911
Recruiting