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

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

开始日期2025-11-01

申办/合作机构

福州宁丹榕康生物医药科技有限公司

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0 项与福州宁丹榕康生物医药科技有限公司相关的专利（医药）

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项与福州宁丹榕康生物医药科技有限公司相关的新闻（医药）

2025-08-22

·同写意

化药1类RK-4注射液IND获国家药监局批准丨会员动态

临床申请申请上市

2025-08-01

·宁丹新药

宁丹榕康|化药1类RK-4注射液IND获国家药监局批准

点击蓝字关注我们2025年07月25日，宁丹新药全资子公司福州宁丹榕康生物医药科技有限公司（简称“宁丹榕康”）化药1类RK-4注射液获得国家药监局颁发的药物临床试验批准通知书（2025LP01893）。RK-4注射液是由宁丹榕康生物医药科技有限公司开发，具有独立知识产权的全球首个通过颅骨骨髓腔注射治疗急性大脑半球大面积梗死新药品种。大脑半球大面积梗死（large hemispheric infarction, LHI）是涉及前循环区域二分之一到三分之二的梗塞，伴或不伴大脑前动脉/大脑后动脉供血区域梗死，约占缺血性脑卒中的10%。即使经过积极的内科治疗，其病死率仍高达60%~80%；约2/3的生存患者遗留严重残疾。因此该现状提示，目前LHI缺乏有效治疗手段，给社会造成沉重负担，具有重大临床需求。RK-4注射液经颅骨骨髓腔注射后，药物能快速进入脑实质，并以有效浓度分布到病灶部位，为LHI患者提供了全新的治疗手段。宁丹榕康拟于近期启动临床研究。撰稿|华垚编辑|朱雯封面|沙蕊审核|陈荣余鹏关于宁丹宁丹新药是一家聚焦于中枢神经系统疾病（CNS）领域新药研发和产业化的创新型公司，拥有全流程、全链条的新药研发平台和自主研发能力，国家级高新技术企业、长三角创新研发型企业、江苏省专精特新中小企业。公司项目管线主要用于卒中、颅内肿瘤、认知障碍、情感障碍、神经病理性疼痛、脑小血管病等多个高发中枢相关疾病，目前分别处于临床中和临床前研究阶段。更多信息请访问：https://www.neurodawn.cn关于宁丹榕康福州宁丹榕康生物医药科技有限公司，成立于2025年，是宁丹新药技术股份有限公司持股的全资子公司，企业注册资本5000万人民币。公司立足福州新区生物医药创新高地，致力于新型药物研发递送技术和核酸药物的开发。

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