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The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours.
The main question the study aims to answer are:
During Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - JX10 (1mg/kg) | Experimental |
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| Part 1 - JX10 (3mg/kg) | Experimental |
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| Part 1 - Placebo | Placebo Comparator |
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| JX10 Part 2 - (1 or 3 mg/kg) | Experimental |
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| Part 2 - Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JX10 | Drug | JX10 is a thrombolytic agent. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days | 90 days | |
| Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization | Within 36 hours post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days | 90 days | |
| Proportion of participants with functional independence at 90 days | Functional independence: mRS score 0-2 | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
Radiographic findings pre-randomization of any of the following:
Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count < 100,000/μL, international normalized ratio > 1.7, aPTT > 40 seconds, or prothrombin time > 15 seconds.
Major trauma, surgery, or invasive procedures.
Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.
Pre-treatment blood glucose > 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose < 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corxel Pharmaceuticals Study Information Center | Contact | 201-268-3723 | Information.center@corxelbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Senior Director, Clinical Operations | Corxel Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corxel Investigational Site | Recruiting | Long Beach | California | 90806 | United States |
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| Placebo | Drug | Placebo is being used as the comparator. |
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| Incidence of adverse events (AEs) and serious adverse events (SAEs) | 90 days |
| Incidence of major bleeding within 24 hours and 14 days of study treatment | Within 24 hours and 14 days of study treatment |
| Corxel Investigational Site | Recruiting | Sacramento | California | 95817 | United States |
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| Corxel Investigational Site | Recruiting | Colorado Springs | Colorado | 80909 | United States |
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| Corxel Investigational Site | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
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| Corxel Investigational Site | Recruiting | Delray Beach | Florida | 33484 | United States |
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| Corxel Investigational Site | Recruiting | Chicago | Illinois | 60616 | United States |
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| Corxel Investigational Site | Recruiting | Wichita | Kansas | 67214 | United States |
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| Corxel Investigational Site | Recruiting | Baltimore | Maryland | 21215 | United States |
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| Corxel Investigational Site | Recruiting | Kalamazoo | Michigan | 49048 | United States |
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| Corxel Investigational Site | Recruiting | Traverse City | Michigan | 49684 | United States |
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| Corxel Investigational Site | Recruiting | St Louis | Missouri | 63110 | United States |
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| Corxel Investigational Site | Recruiting | Great Neck | New York | 11021 | United States |
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| Corxel Investigational Site | Recruiting | New York | New York | 10029 | United States |
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| Corxel Investigational Site | Recruiting | Toledo | Ohio | 43606 | United States |
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| Corxel Investigational Site | Recruiting | Tulsa | Oklahoma | 74104 | United States |
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| Corxel Investigational Site | Recruiting | Dallas | Texas | 75246 | United States |
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| Corxel Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
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| Corxel Investigational Site | Recruiting | Ghent | 9000 | Belgium |
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| Corxel Investigational Site | Recruiting | Blagoevgrad | Bulgaria |
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| Corxel Investigational Site | Recruiting | Burgas | Bulgaria |
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| Corxel Investigational Site | Recruiting | Pleven | Bulgaria |
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| Corxel Investigational Site | Recruiting | Plovdiv | Bulgaria |
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| Corxel Investigational Site | Recruiting | Sofia | 1606 | Bulgaria |
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| Corxel Investigational Site | Recruiting | Edmonton | Canada |
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| Corxel Investigational Site | Recruiting | Kingston | Canada |
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| Corxel Investigational Site | Recruiting | Baotou | China |
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| Corxel Investigational Site | Recruiting | Beijing | China |
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| Corxel Investigational Site | Recruiting | Beijing | China |
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| Corxel Investigational Site | Recruiting | Changchun | China |
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| Corxel Investigational Site | Recruiting | Guangzhou | China |
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| Corxel Investigational Site, | Recruiting | Harbin | China |
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| Corxel Investigational Site | Recruiting | Harbin | China |
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| Corxel Investigational Site | Recruiting | Kaili | China |
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| Corxel Investigational Site | Recruiting | Linfen | China |
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| Corxel Investigational Site | Recruiting | Shanghai | China |
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| Corxel Investigational Site | Recruiting | Shenyang | China |
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| Corxel Investigational Site | Recruiting | Suzhou | China |
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| Corxel Investigational Site | Recruiting | Weifang | China |
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| Corxel Investigational Site | Recruiting | Xuzhou | China |
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| Corxel Investigational site | Recruiting | Lille | France |
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| Corxel Investigational site | Recruiting | Paris | France |
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| Corxel Investigational Site | Recruiting | Altenburg | Germany |
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| Corxel Investigational Site | Recruiting | Leipzig | Germany |
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| Corxel Investigational Site | Recruiting | Lübeck | Germany |
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| Corxel Investigational Site | Recruiting | Trier | Germany |
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| Corxel Investigational Site | Recruiting | Athens | Greece |
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| Corxel Investigational Site | Recruiting | Chaïdári | Greece |
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| Corxel Investigational Site | Recruiting | Pátrai | Greece |
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| Corxel Investigational Site | Recruiting | Thessaloniki | Greece |
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| Corxel Investigational Site | Recruiting | Pavia | Italy |
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| Corxel Investigational Site | Recruiting | Roma | Italy |
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| Corxel Investigational Site | Recruiting | Fukuoka | Japan |
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| Corxel Investigational Site | Recruiting | Hyōgo | Japan |
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| Corxel Investigational site | Recruiting | Ibaraki | Japan |
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| Corxel Investigational Site | Recruiting | Kamakura | Japan |
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| Corxel Investigational Site | Recruiting | Meguro City | Japan |
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| Corxel Investigational Site | Recruiting | Mitaka | Japan |
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| Corxel Investigational Site | Recruiting | Miyagi | Japan |
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| Corxel Investigational site | Recruiting | Toyota | Japan |
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| Corxel Investigational Site | Recruiting | Yamagata | Japan |
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| Corxel Investigational Site | Recruiting | Yamaguchi | Japan |
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| Corxel Investigational Site | Recruiting | Daugavpils | Latvia |
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| Corxel Investigational Site | Recruiting | Riga | Latvia |
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| Corxel Investigational Site | Recruiting | Kaunas | Lithuania |
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| Corxel Investigational Site | Recruiting | Vilnius | Lithuania |
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| Corxel Investigational Site | Recruiting | Kuching | Malaysia |
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| Corxel Investigational Site | Recruiting | Braga | Portugal |
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| Corxel Investigational Site | Recruiting | Loures | Portugal |
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| Corxel Investigational Site | Recruiting | Belgrade | Serbia |
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| Corxel Investigational Site | Recruiting | Kragujevac | Serbia |
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| Corxel Investigational Site | Recruiting | Niš | Serbia |
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| Corxel Investigational Site | Recruiting | Novi Sad | Serbia |
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| Corxel Investigational Site | Recruiting | Seoul | South Korea |
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| Corxel Investigational Site | Recruiting | A Coruña | Spain |
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| Corxel Investigational Site | Recruiting | Albacete | Spain |
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| Corxel Investigational Site | Recruiting | Barcelona | Spain |
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| Corxel Investigational Site | Recruiting | Girona | Spain |
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| Corxel Investigational Site | Recruiting | Madrid | Spain |
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| Corxel Investigational Site | Recruiting | Málaga | Spain |
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| Corxel Investigational Site | Recruiting | Seville | Spain |
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| Corxel Investigational Site | Recruiting | Valencia | Spain |
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| Corxel Investigational Site | Recruiting | Bangkok | Thailand |
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| Corxel Investigational Site | Recruiting | Khon Kaen | Thailand |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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