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A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)
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%.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Site 121
Alexander City, Alabama, United States
Site 130
Birmingham, Alabama, United States
Site 139
Birmingham, Alabama, United States
Site 138
Huntsville, Alabama, United States
Site 111
Phoenix, Arizona, United States
Site 127
Little Rock, Arkansas, United States
Site 128
Huntington Beach, California, United States
Site 157
Los Angeles, California, United States
Site 158
Orange, California, United States
Site 116
Pasadena, California, United States
Start Date
March 28, 2024
Primary Completion Date
December 31, 2025
Completion Date
June 30, 2026
Last Updated
August 22, 2025
282
ESTIMATED participants
JK07
DRUG
Placebo
DRUG
Lead Sponsor
Salubris Biotherapeutics Inc
NCT07057466
NCT07093528
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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