Study of JK07 in Patients With Chronic Heart Failure

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
Salubris Biotherapeutics Inc
Study ID
NCT06369298
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • JK07 — DRUG
    JK07 is a fully human anti-human epidermal growth factor receptor 3 (also known as ErbB3 or HER3) antibody fused with the epidermal growth factor (EGF)-domain of Neuregulin (NRG)-1b protein.
  • Placebo — DRUG
    0.9% sodium chloride

Study Details

This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. There will be 2 cohorts in this study: Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%. Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.

Key Dates

Start date
Mar 28, 2024
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
282 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: JK07 low dose
    JK07 administered by intravenous (IV) infusion
  • Active Comparator: JK07 high dose
    JK07 administered by intravenous (IV) infusion
  • Placebo Comparator: Placebo
    Placebo administered by intravenous (IV) infusion

Primary Outcome Measure

Safety - Cohort 1 [ Time Frame: Study entry through week 52 ]

Locations (51)

FacilityCityStateZIPSite coordinators
Site 121Alexander CityAlabama35010-
Site 130BirminghamAlabama35211-
Site 139BirminghamAlabama35294-
Site 138HuntsvilleAlabama35801-
Site 111PhoenixArizona85016-
Site 127Little RockArkansas72205-
Site 128Huntington BeachCalifornia92648-
Site 157Los AngelesCalifornia90033-
Site 158OrangeCalifornia92868-
Site 116PasadenaCalifornia91105-
Site 129Santa MariaCalifornia93454-
Site 102StanfordCalifornia94305-
Site 113TorranceCalifornia90502-
Site 133VistaCalifornia92081-
Site 161Coral GablesFlorida33134-
Site 114HialeahFlorida33016-
Site 162Miami LakesFlorida33014-
Site 159NaplesFlorida34104-
Site 136AtlantaGeorgia30343-
Site 143BoiseIdaho83712-
Site 160ChicagoIllinois60611-
Site 154Park RidgeIllinois60068-
Site 137Fort WayneIndiana46804-
Site 112IndianapolisIndiana46250-
Site 104CovingtonLouisiana70433-
Site 118BaltimoreMaryland21201-
Site 119BostonMassachusetts02114-
Site 122Bloomfield HillsMichigan48304-
Site 150Farmington HillsMichigan48334-
Site 107RochesterMinnesota55905-
Site 105St LouisMissouri63136-
Site 106St LouisMissouri63110-
Site 144BrickNew Jersey08724-
Site 153ValhallaNew York10595-
Site 152AshevilleNorth Carolina28803-
Site 109CaryNorth Carolina27518-
Site 140CharlotteNorth Carolina28204-
Site 145DurhamNorth Carolina27710-
Site 117CincinnatiOhio45219-
Site 100ClevelandOhio44195-
Site 135Oklahoma CityOklahoma73135-
Site 101PortlandOregon97239-
Site 155YorkPennsylvania17403-
Site 110DallasTexas75235-
Site 115DallasTexas75246-
Site 103HoustonTexas77030-
Site 149TomballTexas77375-
Site 148ArlingtonVirginia22205-
Site 123Falls ChurchVirginia22042-
Site 126NorfolkVirginia23507-
Site 163ViennaVirginia22182-

Find similar trials in Alexander City, AL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Site 121· Alexander City, ALSite 130· Birmingham, ALSite 139· Birmingham, ALSite 138· Huntsville, ALSite 111· Phoenix, AZSite 127· Little Rock, AR

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