Transcranial Bone Marrow InjectionPhase 1/2NCT07166380
RK-4 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction
A Phase 1/2 study testing RK-4 injection in people with Transcranial Bone Marrow Injection and RK-4, run by Neurodawn Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transcranial Bone Marrow Injection, RK-4, Acute Large Hemispheric Infarction
- What is being tested?
- RK-4 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 19 May 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤ age < 81 years old, gender is not limited;
- The modified Rankin score (mRS) score ≤ 1 point before the onset of stroke;
- 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);
- Clinical symptoms, signs and imaging diagnosed as cerebral infarction in the middle cerebral artery blood supply area, and the following characteristics are met:
- 16≤NIHSS score ≤32 points, sum of the fifth upper limb and sixth lower limb scores≥6;
- 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.
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- If vascular reperfusion therapy is performed, the treatment is not effective and the following conditions are met:
- Extended thrombolytic grading (eTICI) = 2a;
- 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.
- Subjects or their legal representatives voluntarily sign the informed consent form.
Who cannot join
- -
- Those who meet one of the following items at screening cannot be enrolled:
- Concurrent cerebrovascular disease meets one of the following conditions:
- Combined with acute cerebral hemorrhage and subarachnoid hemorrhage;
- Combined with acute posterior circulation cerebral infarction, or severe posterior circulation vascular stenosis (>70%);
- Imaging suggests bilateral involvement of the cerebral infarction area;
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- 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
- Hemorrhage transformation in the infarct area, the hematoma area ≥ 30% of the infarcted area, and has an obvious mass occupancy effect;
- 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;
- Planned cranial decompression flap decompression at screening;
- Refractory hypertension (systolic blood pressure >200mmHg or diastolic blood >110mmHg) or hypotension (systolic blood pressure <70mmHg or diastolic blood pressure <50mmHg) that is difficult to control with medication;
- Abnormal blood glucose (random venous blood glucose < 2.8mmol/L or >23mmol/L);
- Obvious abnormal liver function indicators or obvious abnormal renal function indicators; Note: Obvious abnormalities in liver function indicators refer to serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); Significant abnormal renal function measures are defined as eGFR less than 60 mL/min/1.73 m² (eGFR is calculated using the CKD-EPI formula).
- Acute ST-segment elevation myocardial infarction (MI), and/or acute decompensated heart failure (according to New York College of Cardiology (NYHA) cardiac function class III and IV) within the past 3 months];
- Contraindications to transcranial bone marrow administration, such as skull fracture, skull infection, subdural/external hematoma, subscalp hematoma, scalp skin or subcutaneous infection, cranial plate obstruction in the past 3 months, etc.;
- Bleeding tendency that is not conducive to operation in the opinion of the investigator, including but not limited to: platelet count <100×109/L, presence of coagulation dysfunction diseases such as hemophilia, etc.;
- Presence of severe or very severe anemia (hemoglobin < 60 g/L);
- Combined with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) that need to be corrected by endotracheal intubation, tracheostomy or ventilator;
- Subjects have severe local or systemic infections within 3 days before screening, including but not limited to severe local symptoms due to infection, such as suppuration, severe pain, tissue necrosis, or clear systemic infection-related symptoms, such as rapid onset of high fever (>38.5°C), rapid heart rate, chills, impaired consciousness, dyspnea, shock, etc. caused by infection;
- Diagnosed serious CNS degenerative diseases, such as Alzheimer's disease (AD), Parkinson's disease (PD) and severe dementia caused by various reasons or mental system diseases (such as schizophrenia, depression, etc.);
- Previously diagnosed with severe systemic disease, with an expected survival of < 90 days;
- Known allergy to any component of the treatment drug and contrast agent during the study process;
- Subjects who are pregnant, lactating, or have possible pregnancy and plan to become pregnant;
- Subjects are unable to comply with the study protocol or follow-up requirements;
- Those who have participated in any other interventional clinical trial within 3 months before screening, or are currently participating in any other clinical trial;
- The investigator believes that he is not suitable to participate in this clinical study.
- After enrollment, if the subject is found to have violated the enrollment criteria or met the exclusion criteria; such as the age is found to be greater than or equal to 81 years old or malignant tumors or other aspects that do not meet the inclusion criteria, the investigator can judge whether it is suitable to continue to participate in the study based on the risks and benefits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing TianTan Hospital
Beijing, Beijing Municipality, 100070
lilong wang, 13911666571, yilong528@aliyun.com
About this study
Official title: An Open-label, Blinded Ib/IIa Study Investigating the Treatment of Acute Large Hemispheric Infarction by Transcranial Bone Marrow Injection of RK-4 Injection
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:
Read more
- 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
- Being tested
- RK-4 injection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RK-4 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| RK-4 injection | Experimental | patients will take drug RK-4 (1 mg or 2 mg or 4 mg) by transcranial bone marrow injection once daily for consecutive 3 days. Receives: Drug: RK-4 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of physical examinations after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation
Measured: Day1 ~Day 14
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of physical examinations after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation
Measured: Day1 ~Day 14
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of vital signs after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(blood pressure, respiration, pulse, body temperature） will be assessed by according equipments.(electronic sphygmomanometer，thermometer).
Measured: Day1 ~Day 14
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of vital signs after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(blood pressure, respiration, pulse, body temperature） will be assessed by according equipments.(electronic sphygmomanometer，thermometer).
Measured: Day1 ~Day 14
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of 12-lead ECG after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Measured: Day1 ~Day 14
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of 12-lead ECG after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Measured: Day1 ~Day 14
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of laboratory tests after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Measured: Day1 ~Day 14
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of laboratory tests after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Measured: Day1 ~Day 14
Evaluate the safety of RK-4 in patients with LHI by rates of adverse events after treatment.
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment.
The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of CTCAE 5.0.
The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Measured: Day1 ~Day 14
Evaluate the tolerability of RK-4 in patients with LHI by rates of adverse events after treatment.
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment.
The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of CTCAE 5.0.
The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Measured: Day1 ~Day 14
Secondary outcomes (13)
Evaluate the Cmax of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin
Maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Measured: Day1 ~Day 5
Evaluate the AUC 0-t of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration.
Calculated according to linearity trapezoidal rule:
AUC (i, i+1) = (Ti+1-Ti) (Ci+Ci+1) /2, and AUC0-t is the sum of all AUC (i, i + 1)
Measured: Day1 ~Day 5
Evaluate the AUC 0-∞ of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Area under the concentration-time curve from time 0 to infinity (extrapolated). AUC 0-∞ =AUC 0-t + Ct/λz (Ct is the last measured plasma concentration).
Measured: Day1 ~Day 5
Evaluate the Tmax of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time to reach maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Measured: Day1 ~Day 5
Evaluate the t1/2 of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Terminal elimination half-life. t1/2 = ln2/λ
Measured: Day1 ~Day 5
Evaluate the λz of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression.
Measured: Day1 ~Day 5
Evaluate the AUC_%Extrap of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin
The percentage of the AUC0-inf that has been extrapolated. AUC_%Extrap = [(AUC0-∞-AUC0-t)/AUC0-∞] × 100%
Measured: Day1 ~Day 5
Evaluate the Vz of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin
Volume of distribution. Vz = Div/AUC0-∞/λz
Measured: Day1 ~Day 5
Evaluate the CL of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Total body clearance. CLz = Div /AUC0-∞
Measured: Day1 ~Day 5
Evaluate the MRT 0-t of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Mean residence time within the time from time zero to the lowest testing plasma concentration. MRT0-t = AUMC0-t/AUC0-t
Measured: Day1 ~Day 5
Evaluate the efficacy of RK-4 in patients with LHI by the proportion of NIHSS score improvement of ≥8 points from baseline
National Institute of Health stroke scale(NIHSS) is a scale used to assess neurological function. it contains 15 items, with a total score of 0-42. The lower the score is, the better neurological function the patient has.
Measured: Day 14
Evaluate the efficacy of RK-4 in patients with LHI by the proportion of NIHSS score improvement of ≥4 points from baseline
National Institute of Health stroke scale(NIHSS) is a scale used to assess neurological function. it contains 15 items, with a total score of 0-42. The lower the score is, the better neurological function the patient has.
Measured: Day 14
Evaluate the efficacy of RK-4 in patients with LHI by the change of NIHSS score from baseline
National Institute of Health stroke scale(NIHSS) is a scale used to assess neurological function. it contains 15 items, with a total score of 0-42. The lower the score is, the better neurological function the patient has.
Measured: Day4, Day8, Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion19 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Bone Marrow InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fuzhou Neurodawn Rongkang Pharmaceutical Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166380
- Sponsor's protocol ID
- RK-4-LC-01
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Blinded Ib/IIa Study Investigating the Treatment of Acute Large Hemispheric Infarction by Transcranial Bone Marrow Injection of RK-4 Injection
- ClinicalTrials.gov ID
- NCT07166380
- Acronym / sponsor ID
- RK-4-LC-01
- Conditions
- Transcranial Bone Marrow Injection, RK-4, Acute Large Hemispheric Infarction, Acute Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fuzhou Neurodawn Rongkang Pharmaceutical Co., Ltd
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 19 May 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RK-4 injection | Experimental | Drug: RK-4 injectionpatients will take drug RK-4 (1 mg or 2 mg or 4 mg) by transcranial bone marrow injection once daily for consecutive 3 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18≤ age < 81 years old, gender is not limited;
- The modified Rankin score (mRS) score ≤ 1 point before the onset of stroke;
- 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);
- Clinical symptoms, signs and imaging diagnosed as cerebral infarction in the middle cerebral artery blood supply area, and the following characteristics are met:
- If vascular reperfusion therapy is performed, the treatment is not effective and the following conditions are met:
Key exclusion criteria (27 listed)
- -
- Concurrent cerebrovascular disease meets one of the following conditions:
- Hemorrhage transformation in the infarct area, the hematoma area ≥ 30% of the infarcted area, and has an obvious mass occupancy effect;
- 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;
- Planned cranial decompression flap decompression at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RK-4 injectionpatients 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. | Drug | RK-4 injection |
Primary outcome
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of vital signs after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(blood pressure, respiration, pulse, body temperature） will be assessed by according equipments.(electronic sphygmomanometer，thermometer).
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of vital signs after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(blood pressure, respiration, pulse, body temperature） will be assessed by according equipments.(electronic sphygmomanometer，thermometer).
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of 12-lead ECG after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of 12-lead ECG after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Evaluate the tolerability of RK-4 in patients with LHI by incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: Day1 ~Day 14
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Evaluate the safety of RK-4 in patients with LHI by rates of adverse events after treatment.
Time frame: Day1 ~Day 14
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment. The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of CTCAE 5.0. The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Evaluate the tolerability of RK-4 in patients with LHI by rates of adverse events after treatment.
Time frame: Day1 ~Day 14
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment. The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of CTCAE 5.0. The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
13 secondary outcomes
Evaluate the Cmax of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin
Time frame: Day1 ~Day 5
Evaluate the AUC 0-t of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time frame: Day1 ~Day 5
Evaluate the AUC 0-∞ of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time frame: Day1 ~Day 5
Evaluate the Tmax of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time frame: Day1 ~Day 5
Evaluate the t1/2 of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time frame: Day1 ~Day 5
Evaluate the λz of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time frame: Day1 ~Day 5
Evaluate the AUC_%Extrap of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin
Time frame: Day1 ~Day 5
Evaluate the Vz of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin
Time frame: Day1 ~Day 5
Evaluate the CL of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time frame: Day1 ~Day 5
Evaluate the MRT 0-t of single ascending doses of RK-4 in patients with LHI by venous blood and Phoenix WinNonlin.
Time frame: Day1 ~Day 5
Evaluate the efficacy of RK-4 in patients with LHI by the proportion of NIHSS score improvement of ≥8 points from baseline
Time frame: Day 14
Evaluate the efficacy of RK-4 in patients with LHI by the proportion of NIHSS score improvement of ≥4 points from baseline
Time frame: Day 14
Evaluate the efficacy of RK-4 in patients with LHI by the change of NIHSS score from baseline
Time frame: Day4, Day8, Day14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RK-4 injection in people with Transcranial Bone Marrow Injection and RK-4, run by Neurodawn Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yilong wang (13911666571, yilong528@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of RK-4 in patients with LHI by incidence of subject getting abnormal results of physical examinations after treatment. (time frame: Day1 ~Day 14). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.