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NCT06990867PHASE2, PHASE3Recruiting

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Corxel Pharmaceuticals

Start Date

5/15/2025

Completion Date

12/31/2029

Summary

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: 1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. 2. Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS. 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.

Eligibility Criteria

Age Range: 18 years to 90 years

Inclusion Criteria: 1. Age ≥ 18 and ≤ 90 years old. 2. Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA). 3. Radiographic evidence of salvageable tissue. 4. Pre-treatment score of NIHSS ≥ 5. Exclusion Criteria: 1. Radiographic findings pre-randomization of any of the following: 1. Large core infarction, or 2. Occlusion in more than 1 vascular territory, or 3. Significant mass effect or clinically significant cerebral edema, or 4. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or 5. Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic. 2. Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding. 3. Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy. 4. 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. 5. Major trauma, surgery, or invasive procedures. 6. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study. 7. 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.

Interventions

DRUG

JX10

DRUG

Placebo

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Conditions

Acute Ischemic Stroke

Locations

Corxel Investigational Site

Long Beach, California 90806

United States

Corxel Investigational Site

Sacramento, California 95817

United States

Corxel Investigational Site

Colorado Springs, Colorado 80909

United States

Corxel Investigational Site

Washington D.C., District of Columbia 20007

United States

Corxel Investigational Site

Delray Beach, Florida 33484

United States

Corxel Investigational Site

Chicago, Illinois 60616

United States

Corxel Investigational Site

Wichita, Kansas 67214

United States

Corxel Investigational Site

Baltimore, Maryland 21215

United States

Corxel Investigational Site

Kalamazoo, Michigan 49048

United States

Corxel Investigational Site

Traverse City, Michigan 49684

United States

Corxel Investigational Site

St Louis, Missouri 63110

United States

Corxel Investigational Site

Great Neck, New York 11021

United States

Corxel Investigational Site

New York, New York 10029

United States

Corxel Investigational Site

Toledo, Ohio 43606

United States

Corxel Investigational Site

Tulsa, Oklahoma 74104

United States

Corxel Investigational Site

Dallas, Texas 75246

United States

Corxel Investigational Site

Houston, Texas 77030

United States

Corxel Investigational Site

Ghent, 9000

Belgium

Corxel Investigational Site

Blagoevgrad,

Bulgaria

Corxel Investigational Site

Burgas,

Bulgaria

Corxel Investigational Site

Pleven,

Bulgaria

Corxel Investigational Site

Plovdiv,

Bulgaria

Corxel Investigational Site

Sofia, 1606

Bulgaria

Corxel Investigational Site

Edmonton,

Canada

Corxel Investigational Site

Kingston,

Canada

Corxel Investigational Site

Baotou,

China

Corxel Investigational Site

Beijing,

China

Corxel Investigational Site

Beijing,

China

Corxel Investigational Site

Changchun,

China

Corxel Investigational Site

Guangzhou,

China

Corxel Investigational Site,

Harbin,

China

Corxel Investigational Site

Harbin,

China

Corxel Investigational Site

Kaili,

China

Corxel Investigational Site

Linfen,

China

Corxel Investigational Site

Shanghai,

China

Corxel Investigational Site

Shenyang,

China

Corxel Investigational Site

Suzhou,

China

Corxel Investigational Site

Weifang,

China

Corxel Investigational Site

Xuzhou,

China

Corxel Investigational site

Lille,

France

Corxel Investigational site

Paris,

France

Corxel Investigational Site

Altenburg,

Germany

Corxel Investigational Site

Leipzig,

Germany

Corxel Investigational Site

Lübeck,

Germany

Corxel Investigational Site

Trier,

Germany

Corxel Investigational Site

Athens,

Greece

Corxel Investigational Site

Chaïdári,

Greece

Corxel Investigational Site

Pátrai,

Greece

Corxel Investigational Site

Thessaloniki,

Greece

Corxel Investigational Site

Pavia,

Italy

Corxel Investigational Site

Roma,

Italy

Corxel Investigational Site

Fukuoka,

Japan

Corxel Investigational Site

Hyōgo,

Japan

Corxel Investigational site

Ibaraki,

Japan

Corxel Investigational Site

Kamakura,

Japan

Corxel Investigational Site

Meguro City,

Japan

Corxel Investigational Site

Mitaka,

Japan

Corxel Investigational Site

Miyagi,

Japan

Corxel Investigational site

Toyota,

Japan

Corxel Investigational Site

Yamagata,

Japan

Corxel Investigational Site

Yamaguchi,

Japan

Corxel Investigational Site

Daugavpils,

Latvia

Corxel Investigational Site

Riga,

Latvia

Corxel Investigational Site

Kaunas,

Lithuania

Corxel Investigational Site

Vilnius,

Lithuania

Corxel Investigational Site

Kuching,

Malaysia

Corxel Investigational Site

Braga,

Portugal

Corxel Investigational Site

Loures,

Portugal

Corxel Investigational Site

Belgrade,

Serbia

Corxel Investigational Site

Kragujevac,

Serbia

Corxel Investigational Site

Niš,

Serbia

Corxel Investigational Site

Novi Sad,

Serbia

Corxel Investigational Site

Seoul,

South Korea

Corxel Investigational Site

A Coruña,

Spain

Corxel Investigational Site

Albacete,

Spain

Corxel Investigational Site

Barcelona,

Spain

Corxel Investigational Site

Girona,

Spain

Corxel Investigational Site

Madrid,

Spain

Corxel Investigational Site

Málaga,

Spain

Corxel Investigational Site

Seville,

Spain

Corxel Investigational Site

Valencia,

Spain

Corxel Investigational Site

Bangkok,

Thailand

Corxel Investigational Site

Khon Kaen,

Thailand