JX10 for Stroke

(ORION Trial)

Recruiting at 1 trial location

Overseen By Corxel Pharmaceuticals Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Corxel Pharmaceuticals

Disqualifiers: Hypertension, Coagulopathy, Major trauma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

740 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Senior Director, Clinical Operations

Principal Investigator

Corxel Pharmaceuticals

Eligibility Criteria

This trial is for individuals who have had an Acute Ischemic Stroke (AIS) and seek treatment within 4.5 to 24 hours of the stroke occurring. Specific eligibility criteria details are not provided, but typically include factors like age, health status, and time since stroke onset.

Inclusion Criteria

I am between 18 and 90 years old.

Radiographic evidence of salvageable tissue

Pre-treatment score of NIHSS ≥ 5

Exclusion Criteria

Radiographic findings pre-randomization of large core infarction

Radiographic findings pre-randomization of occlusion in more than 1 vascular territory

Radiographic findings pre-randomization suggesting that the intracranial occlusion is chronic

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants are randomized to receive JX10 (1mg/kg or 3mg/kg) or placebo

4 weeks

Treatment Part 2

Participants receive JX10 (optimal dose from Part 1) or placebo

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• JX10

Trial Overview The study tests JX10 against a placebo in two parts: initially patients receive different doses of JX10 or placebo randomly; then they get either the best dose from Part 1 or a placebo to see if it helps recovery after AIS.

Participant Groups

Group I: Part 1 - JX10 (3mg/kg) Experimental Treatment 1 Intervention

Group II: Part 1 - JX10 (1mg/kg) Experimental Treatment 1 Intervention

Group III: JX10 Part 2 - (1 or 3 mg/kg) Experimental Treatment 1 Intervention

Group IV: Part 1 - Placebo Placebo Group 1 Intervention

Group V: Part 2 - Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Corxel Pharmaceuticals

Lead Sponsor

Trials

9

Recruited

1,500+