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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JK07 low dose | Active Comparator | JK07 administered by intravenous (IV) infusion |
|
| JK07 high dose | Active Comparator | JK07 administered by intravenous (IV) infusion |
|
| Placebo | Placebo Comparator | Placebo administered by intravenous (IV) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Cohort 1 | Incidence and severity of treatment emergent adverse events | Study entry through week 52 |
| Efficacy - Cohort 1 | Change in LVEF measured by 2D-TTE | Baseline through week 26 |
| Safety - Cohort 2 | Incidence and severity of treatment emergent adverse events | Study entry through week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 121 | Alexander City | Alabama | 35010 | United States | ||
| Site 130 |
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| Placebo | Drug | 0.9% sodium chloride |
|
| Birmingham |
| Alabama |
| 35211 |
| United States |
| Site 139 | Birmingham | Alabama | 35294 | United States |
| Site 138 | Huntsville | Alabama | 35801 | United States |
| Site 111 | Phoenix | Arizona | 85016 | United States |
| Site 127 | Little Rock | Arkansas | 72205 | United States |
| Site 128 | Huntington Beach | California | 92648 | United States |
| Site 157 | Los Angeles | California | 90033 | United States |
| Site 158 | Orange | California | 92868 | United States |
| Site 116 | Pasadena | California | 91105 | United States |
| Site 129 | Santa Maria | California | 93454 | United States |
| Site 102 | Stanford | California | 94305 | United States |
| Site 113 | Torrance | California | 90502 | United States |
| Site 133 | Vista | California | 92081 | United States |
| Site 161 | Coral Gables | Florida | 33134 | United States |
| Site 114 | Hialeah | Florida | 33016 | United States |
| Site 162 | Miami Lakes | Florida | 33014 | United States |
| Site 159 | Naples | Florida | 34104 | United States |
| Site 136 | Atlanta | Georgia | 30343 | United States |
| Site 143 | Boise | Idaho | 83712 | United States |
| Site 160 | Chicago | Illinois | 60611 | United States |
| Site 154 | Park Ridge | Illinois | 60068 | United States |
| Site 137 | Fort Wayne | Indiana | 46804 | United States |
| Site 112 | Indianapolis | Indiana | 46250 | United States |
| Site 104 | Covington | Louisiana | 70433 | United States |
| Site 118 | Baltimore | Maryland | 21201 | United States |
| Site 119 | Boston | Massachusetts | 02114 | United States |
| Site 122 | Bloomfield Hills | Michigan | 48304 | United States |
| Site 150 | Farmington Hills | Michigan | 48334 | United States |
| Site 107 | Rochester | Minnesota | 55905 | United States |
| Site 106 | St Louis | Missouri | 63110 | United States |
| Site 105 | St Louis | Missouri | 63136 | United States |
| Site 144 | Brick | New Jersey | 08724 | United States |
| Site 153 | Valhalla | New York | 10595 | United States |
| Site 152 | Asheville | North Carolina | 28803 | United States |
| Site 109 | Cary | North Carolina | 27518 | United States |
| Site 140 | Charlotte | North Carolina | 28204 | United States |
| Site 145 | Durham | North Carolina | 27710 | United States |
| Site 117 | Cincinnati | Ohio | 45219 | United States |
| Site 100 | Cleveland | Ohio | 44195 | United States |
| Site 135 | Oklahoma City | Oklahoma | 73135 | United States |
| Site 101 | Portland | Oregon | 97239 | United States |
| Site 155 | York | Pennsylvania | 17403 | United States |
| Site 110 | Dallas | Texas | 75235 | United States |
| Site 115 | Dallas | Texas | 75246 | United States |
| Site 103 | Houston | Texas | 77030 | United States |
| Site 149 | Tomball | Texas | 77375 | United States |
| Site 148 | Arlington | Virginia | 22205 | United States |
| Site 123 | Falls Church | Virginia | 22042 | United States |
| Site 126 | Norfolk | Virginia | 23507 | United States |
| Site 163 | Vienna | Virginia | 22182 | United States |
| Site 202 | Winnepeg | Manitoba | R2H2A6 | Canada |
| Site 203 | Brampton | Ontario | L6Z 4N5 | Canada |
| Site 200 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Site 201 | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Site 305 | Changsha | Hunan | 410005 | China |
| Site 303 | Nanjing | Jiangsu | 210009 | China |
| Site 306 | Jining | Shandong | 272100 | China |
| Site 301 | Chengdu | Sichuan | 610041 | China |
| Site 300 | Beijing | 100037 | China |
| Site 304 | Chongqing | 404000 | China |
| Site 156 | Ponce | 00717 | Puerto Rico |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| C565323 | Fibromatosis, Gingival, 2 |
| D054143 | Heart Failure, Systolic |
| D054144 | Heart Failure, Diastolic |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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