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

NCT07166380 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-09-30

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

RK-4 injection

patients with LHI will take drug RK-4 (1 mg or 2 mg or 4 mg) by transcranial bone marrow injection once daily for consecutive 3 days.

Sponsors & Collaborators

  • Fuzhou Neurodawn Rongkang Pharmaceutical Co., Ltd

    collaborator OTHER_GOV

  • Neurodawn Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-20
Primary Completion
2026-02-20
Completion
2026-05-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07166380 on ClinicalTrials.gov