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Study of JK07 in Patients With Chronic Heart Failure
Sponsor: Salubris Biotherapeutics Inc
Summary
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%.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
282
Start Date
2024-03-28
Completion Date
2026-06-30
Last Updated
2025-08-22
Healthy Volunteers
No
Conditions
Interventions
JK07
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
0.9% sodium chloride
Locations (62)
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
Site 129
Santa Maria, California, United States
Site 102
Stanford, California, United States
Site 113
Torrance, California, United States
Site 133
Vista, California, United States
Site 161
Coral Gables, Florida, United States
Site 114
Hialeah, Florida, United States
Site 162
Miami Lakes, Florida, United States
Site 159
Naples, Florida, United States
Site 136
Atlanta, Georgia, United States
Site 143
Boise, Idaho, United States
Site 160
Chicago, Illinois, United States
Site 154
Park Ridge, Illinois, United States
Site 137
Fort Wayne, Indiana, United States
Site 112
Indianapolis, Indiana, United States
Site 104
Covington, Louisiana, United States
Site 118
Baltimore, Maryland, United States
Site 119
Boston, Massachusetts, United States
Site 122
Bloomfield Hills, Michigan, United States
Site 150
Farmington Hills, Michigan, United States
Site 107
Rochester, Minnesota, United States
Site 106
St Louis, Missouri, United States
Site 105
St Louis, Missouri, United States
Site 144
Brick, New Jersey, United States
Site 153
Valhalla, New York, United States
Site 152
Asheville, North Carolina, United States
Site 109
Cary, North Carolina, United States
Site 140
Charlotte, North Carolina, United States
Site 145
Durham, North Carolina, United States
Site 117
Cincinnati, Ohio, United States
Site 100
Cleveland, Ohio, United States
Site 135
Oklahoma City, Oklahoma, United States
Site 101
Portland, Oregon, United States
Site 155
York, Pennsylvania, United States
Site 110
Dallas, Texas, United States
Site 115
Dallas, Texas, United States
Site 103
Houston, Texas, United States
Site 149
Tomball, Texas, United States
Site 148
Arlington, Virginia, United States
Site 123
Falls Church, Virginia, United States
Site 126
Norfolk, Virginia, United States
Site 163
Vienna, Virginia, United States
Site 202
Winnepeg, Manitoba, Canada
Site 203
Brampton, Ontario, Canada
Site 200
Chicoutimi, Quebec, Canada
Site 201
Trois-Rivières, Quebec, Canada
Site 305
Changsha, Hunan, China
Site 303
Nanjing, Jiangsu, China
Site 306
Jining, Shandong, China
Site 301
Chengdu, Sichuan, China
Site 300
Beijing, China
Site 304
Chongqing, China
Site 156
Ponce, Puerto Rico