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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Salubris Biotherapeutics Inc
Study ID
NCT04210375
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • JK07 — DRUG
    Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
  • Matching Placebo — DRUG
    Vehicle control

Study Details

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.

Key Dates

Start date
Sep 21, 2020
Status verified
Jul 2025
Primary completion
Jun 8, 2023
Completion
Jul 7, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: JK07
    Single dose of JK07 administered by intravenous infusion over 60 minutes
  • Placebo Comparator: Matching Placebo
    Single dose of placebo administered by intravenous infusion over 60 minutes

Primary Outcome Measure

Incidence and Severity of Treatment-emergent Adverse Events [Safety and Tolerability] [ Time Frame: Screening to 30 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Arizona College of MedicineTucsonArizona85724-5039-
Stanford University Medical CenterStanfordCalifornia94305-
Harvard Medical School/ Massachusetts General HospitalBostonMassachusetts02114-2696-
Cleveland ClinicClevelandOhio44195-
Oregon Health Science University HospitalPortlandOregon97239-
University of Texas SouthwesternDallasTexas75390-
Houston Methodist HospitalHoustonTexas77030-

Find similar trials in Tucson, AZ

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Arizona College of Medicine· Tucson, AZStanford University Medical Center· Stanford, CAHarvard Medical School/ Massachusetts General Hospital· Boston, MACleveland Clinic· Cleveland, OHOregon Health Science University Hospital· Portland, ORUniversity of Texas Southwestern· Dallas, TX

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