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RK-4 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

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

NCT07166380•Neurodawn Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18≤ age \< 81 years old, gender is not limited;
•2. The modified Rankin score (mRS) score ≤ 1 point before the onset of stroke;
•3. Administration can be completed within 24 hours after the onset of symptoms and signs of neurological deficit (for subjects with stroke after waking up or stroke without witnesses, the last normal time of symptom onset is the time of symptom onset);
•4. Clinical symptoms, signs and imaging diagnosed as cerebral infarction in the middle cerebral artery blood supply area, and the following characteristics are met:
•1. 16≤NIHSS score ≤32 points, sum of the fifth upper limb and sixth lower limb scores≥6;
•2. Imaging suggests the core area of infarction: cerebral blood flow (CBF) in electronic computed scan perfusion imaging (CTP) \< 30% volume or apparent diffusion coefficient (ADC) value in magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequence \< 70-300ml of 620×10-6mm2/s lesion volume or ASPECTS score of 0-6 points. Priority is given to CTP test results. If both CTP and DWI are completed during the screening period and the examination results are inconsistent, the investigator needs to take all information (scanning time, imaging method for optimal response infarct size, etc.) into account and then make a reasonable judgment and record that; ASPECTS scores can be based on CTP or MRI, but CTP is preferred.
•5. If vascular reperfusion therapy is performed, the treatment is not effective and the following conditions are met:
•1. Extended thrombolytic grading (eTICI) = 2a;
•2. NIHSS score did not improve or progressed after vascular reperfusion treatment and the total score was still ≤ 32 points.
•Note: A decrease of 1 point or more is an improvement, and an increase of 1 point or more is progress.
+1 more criteria

Exclusion Criteria

•\-
•Those who meet one of the following items at screening cannot be enrolled:
•1. Concurrent cerebrovascular disease meets one of the following conditions:
•1. Combined with acute cerebral hemorrhage and subarachnoid hemorrhage;
•2. Combined with acute posterior circulation cerebral infarction, or severe posterior circulation vascular stenosis (\>70%);
•3. Imaging suggests bilateral involvement of the cerebral infarction area;
•4. The cause has been diagnosed by TOAST typing before screening, and other etiologies such as intracranial artery dissection, vasculitis, and moyamoya disease have been identified
•2. Hemorrhage transformation in the infarct area, the hematoma area ≥ 30% of the infarcted area, and has an obvious mass occupancy effect;
•3. Presence of clinical signs of cerebral herniation, e.g., unilateral or bilateral pupil dilation, fixation; Cerebral edema-related loss of consciousness (NIHSS 1a\>2 points), or other brainstem reflex loss judged by the investigator caused by cerebral edema or cerebral herniation formation; or other unstable signs of vital signs that are difficult to control;
•4. Planned cranial decompression flap decompression at screening;
+16 more criteria

Locations (1)

Beijing TianTan Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 20, 2025

Primary Completion Date

February 20, 2026

Completion Date

May 19, 2026

Last Updated

September 30, 2025

Enrollment

ESTIMATED participants

Conditions

Transcranial Bone Marrow InjectionRK-4Acute Large Hemispheric InfarctionAcute Ischemic Stroke

Interventions

RK-4 injection

DRUG

Contacts

yilong wang

CONTACT

13911666571 yilong528@aliyun.com