NCT07166380

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

Not yet recruiting Phase 1, PHASE2 Last updated 30 September 2025

What this trial tests

Phase 1, PHASE2 trial testing RK-4 injection in Transcranial Bone Marrow Injection in 18 participants. Not yet recruiting.

Timeline

20 September 2025

Primary endpoint
20 February 2026

19 May 2026

Quick facts

Lead sponsor	Neurodawn Pharmaceutical Co., Ltd.
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	20 September 2025
Primary completion	20 February 2026
Estimated completion	19 May 2026
Sites	1 location across China

Drugs / interventions tested

• RK-4 injection — full drug profile →

Conditions studied

• Transcranial Bone Marrow Injection — all drugs for Transcranial Bone Marrow Injection →
• RK-4 — all drugs for RK-4 →
• Acute Large Hemispheric Infarction — all drugs for Acute Large Hemispheric Infarction →
• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

Neurodawn Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Transcranial Bone Marrow Injection or RK-4. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.