Single-Ascending Dose Study of JK07 in Subjects With HFpEF

Part of paid clinical trials in Stanford, California.

Sponsor
Salubris Biotherapeutics Inc
Study ID
NCT05322616
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 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

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.

Key Dates

Start date
Oct 21, 2022
Status verified
May 2023
Primary completion
May 26, 2023
Completion
May 26, 2023

Study Design

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

Arms

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

Primary Outcome Measure

Safety Assessment [ Time Frame: Screening to Day 28 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-
Harvard Medical School/Massachusetts General HospitalBostonMassachusetts02114-2696-
Mayo ClinicRochesterMinnesota55905-
Washington UniversitySt LouisMissouri63110-
Cleveland ClinicClevelandOhio44195-
Oregon Health and Science University HospitalPortlandOregon97239-
Houston Methodist HospitalHoustonTexas77030-

Find similar trials in Stanford, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Stanford University Medical Center· Stanford, CAHarvard Medical School/Massachusetts General Hospital· Boston, MAMayo Clinic· Rochester, MNWashington University· St Louis, MOCleveland Clinic· Cleveland, OHOregon Health and Science University Hospital· Portland, OR

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