NCT07203521

RK-4 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction

An Open-label, Blinded Phase II Study Investigating the Treatment of Acute Large Hemispheric Infarction by Transcranial Bone Marrow Injection of RK-4 Injection

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Fuzhou Neurodawn Rongkang Pharmaceutical Co., Ltd · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An open-label, blinded phase II study investigating the treatment of acute large hemispheric infarction by transcranial bone marrow injection of RK-4 injection For subjects with acute large hemispheric infarction who are contraindicated to vascular recanalization or have poor response to vascular recanalization therapy, the safety, tolerability, and PK characteristics of RK-4 injection injected into the brain cell marrow through the cranial bone marrow will be preliminarily evaluated, and the efficacy will be preliminarily explored. The main questions it aims to answer are: * The efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow. * If drug RK-4 is safe and tolerate in the patients with LHI? Researchers will analyze data from different groups, includes cranial administration group and conventional treatment group , to see efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow and If drug RK-4 is safe and tolerate in the patients with LHI . Participants will: * Take drug RK-4 (2mg/mL, 1mL) by transcranial bone marrow injection once daily for consecutive 3 days or just receive conventional treatments. * Truthfully provide medical history and "previous participation in clinical trials" and a statement of no history of mental disorders. * Take the drug at the specified time every day according to the dosage prescribed by the doctor * Receive the investigational drug as instructed by the doctor and visiting as required * Tell the investigators about any medications (including chemicals, biological drugs, proprietary Chinese medicines, etc.) and related treatments you take during the study * unpermitted stop the investigational drug yourself at the end of the study or when you decide to withdraw from the study, you need to stop the investigational drug as directed by your doctor to ensure your safety * take reasonable contraception actions * unallowed to use unmarketed drugs or other clinical trial drugs during the study

Conditions

• Acute Large Hemispheric Infarction Stroke
• Transcranial Bone Marrow Injection
• RK-4
• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	RK-4 injection	take drug RK-4 (2mg/mL, 1mL) by transcranial bone marrow injection once daily for consecutive 3 days.
OTHER	conventional treatment	conventional treatment of LHI other than RK-4

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-04-30
• Completion: 2026-10-07
• First posted: 2025-10-02
• Last updated: 2025-10-02