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

StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record status
This record was last updated September 30, 2025 (before its estimated February 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Secondary endpoints: details revised at 3 of 13 entries
    • Study title revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
An open-label, blinded Ib/IIa 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: * If drug RK-4 is safe and tolerate in the patients with LHI? * What the pharmacokinetic profiles of RK-4 injection injected into the brain cell marrow through the cranial bone marrow? * The efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow Researchers will analyze data from different groups, includes low dose group (1mg,QD), medium dose group(2mg,QD), high dose group(4mg,QD), to see If drug RK-4 is safe and tolerate in the patients with LHI and the pharmacokinetic profiles and efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow. Participants will: * Take drug RK-4 (1 mg or 2 mg or 4 mg) by transcranial bone marrow injection once daily for consecutive 3 days. * 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
Trial Details
NCT Number NCT07166380
Lead Sponsor Neurodawn Pharmaceutical Co., Ltd.
Collaborators: Fuzhou Neurodawn Rongkang Pharmaceutical Co., Ltd
Conditions
(from sponsor)
Transcranial Bone Marrow Injection, RK-4, Acute Large Hemispheric Infarction, Acute Ischemic Stroke
Related terms Ischemic Stroke
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov