Acute Ischemic StrokePhase 2KPCXM18NCT07279493
Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke
A Phase 2 study testing The KPCXM18 injection in people with Acute Ischemic Stroke, run by Kunming Pharmaceuticals, Inc. at 23 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- The KPCXM18 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 23 sitesChina
- Study dates
- 22 Nov 2025to 18 Oct 2026
- Phase
- Phase 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
- 1. Age 18 to 80 years old (including 18 years old and 80 years old, based on the date of signing the informed consent form), male or female;
- 2.Diagnosed with acute ischemic stroke according to the " Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023 ";
- 3.During the screening process, it is required that the ischemic stroke should occur within 12 hours after the onset, and it is expected that the investigational drug can be started within 12 hours after the onset; note: The onset time is calculated from the time when the ischemic stroke symptoms appear, If the onset occurs during sleep, the time of onset should be considered as the last time the patient was observed to be normal;
- 4.Before intravenous thrombolysis, 6 points ≤ NIHSS score ≤ 24 points, and the sum of upper limb and lower limb score ≥2 points;
- 5.The patients who first attacked, or the patients who had a good prognosis after the last attacked , (mRS score was ≤1 before the onset of the disease );
- 6.The subject has received or plans to receive standard intravenous thrombolysis treatment after this onset;
- 7.The subject can understand and follow the research process and voluntarily signs the research informed consent form (the informed consent form is signed by the subject or the legal representative).
Who cannot join
- 1. Patients with intracranial hemorrhagic diseases confirmed by Imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, Traumatic cerebral hemorrhage, etc;
- 2. Patients who have received or plan to receive endovascular interventional treatment (including endovascular mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty and stenting) or patients with arteriovenous bridging therapy after this onset;
- 3. Patients with disturbance of consciousness (NIHSS score Ia>1 point);
- 4. Patient has a history of intracranial hemorrhage before;
- 5. Patient who have a history of epilepsy or who experienced epileptic symptoms during a stroke;
- 6. The patient with other mental illness (such as severe mental disorders, dementia) and combined conditions such as limb movement disorders may influence their neurological function tests;
Show all 18Show fewer
- 7. Patients with acute myocardial infarction, cardiac interventional therapy, or heart failure (grade III and IV according to NYHA) within the past 1 month;
- 8. Patients with malignant tumors, serious diseases of blood, digestion or other systems or diseases with bleeding tendencies (such as hemophilia, etc.), and the expected survival time is not more than 3 months;
- 9. Despite active antihypertensive therapy, hypertension remains uncontrolled: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg;
- 10.Patients with severe liver function impairment, or ALT, AST > 2.0× ULN;
- 11.Patients with severe renal impairment, or serum creatinine > 1.5× ULN;
- 12.Patients who have used neuroprotective drugs (including Edaravone, Edaravone Dexborneol, Butylphthalide, Piracetam, Urinary Kallidinogenase, Ginkgolide, Ginkgo Diterpene Lactone, Safflower Extract and Aceglutamide Injection, etc.) after the onset of this illness;
- 13.Patients with severe allergies, hypersensitivity to at least two or more types of drugs, or known to be allergic to any ingredient or excipient of the investigational drug;
- 14.Patients with a history of major surgery within 1 month before screening;
- 15.Patients with a history of drug abuse within 3 month before screening;
- 16.Patients who participated in or are currently participating in other clinical trials within 3 month prior to this study;
- 17.Pregnancy, lactation. or patients who have a family plan within 3 months of the first dose and who are unwilling to use contraception;
- 18.The investigator considers that patients are not suitable for clinical trials.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
The People's Hospital Of Anyang City
Anyang, Henan
- Recruiting
Beijing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality
- Recruiting
Cangzhou Central Hospital
Cangzhou, Hebei
- Recruiting
Da Qing Long Nan Hospital
Daqing, Heilongjiang
- Recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang
- Recruiting
Sinopharm Tongmei General Hospital
Datong, Shanxi
- Recruiting
Hengshui People's Hospital
Hengshui, Hebei
- Recruiting
Jiaxing Second Hospital
Jiaxing, Zhejiang
- Recruiting
Linfen Central Hospital
Linfen, Shanxi
- Recruiting
Linfen People's Hospital
Linfen, Shanxi
- Recruiting
First People's Hospital Of Tancheng
Linyi, Shandong
- Recruiting
Linyi People's Hospital
Linyi, Shandong
- Recruiting
Meihakou Central Hospital
Meihekou, Jilin
- Recruiting
Nanshi Hospital Of Nanyang
Nanyang, Henan
- Recruiting
Nanyang Second General Hospital
Nanyang, Henan
- Recruiting
The First Affiliated Hospital Of Nanyang Medical College
Nanyang, Henan
- Recruiting
Affiliated Central Hospital Of Shenyang Medical College
Shenyang, Liaoning
- Recruiting
The First People's Hospital Of Shenyang
Shenyang, Liaoning
- Recruiting
The People's Hospital Of Liaoning Province
Shenyang, Liaoning
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
- Recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong
- Recruiting
Yan'an University Xianyang Hospital
Xianyang, Shaanxi
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase Ⅱb Clinical Trial to Evaluate the Efficacy and Safety of the KPCXM18 Injection at Different Doses in The Treatment of Acute Ischemic Stroke
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
Read the detailed description
Trial Objectives:
The primary objective is to evaluate the efficacy of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
The secondary objective is to evaluate the safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke and based on the population pharmacokinetic analysis method, explore the PK characteristics of the KPCXM18 injection in patients with acute ischemic stroke, and provide a basis for the design of the phase III clinical study.
Trial Design:
This trial is a multicenter, randomized, double-blind, parallel, placebo-controlled design. The subjects will be randomly assigned to the low-dose group, the high-dose group, and the placebo group at a ratio of 1:1:1, with 100 subjects in each group, totaling 300 subjects. The treatment will be administered continuously for 12±2 days to explore the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- The KPCXM18 injection, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The KPCXM18 injectionDrug
Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 12±2 days.
PlaceboDrug
Intravenous infusion twice a day with an interval of 12±2 hours for 12±2 days.
The KPCXM18 injectionDrug
Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 12±2 days.
| Study group | Role | What they receive |
|---|---|---|
| low-dose group （The KPCXM18 injection） | Experimental | The KPCXM18 injection (60 mg BID) Receives: Drug: The KPCXM18 injection |
| high-dose group （The KPCXM18 injection） | Experimental | The KPCXM18 injection (100 mg BID) Receives: Drug: The KPCXM18 injection |
| Placebo | Placebo comparator | Placebo of the KPCXM18 injection( BID ) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
Proportion of subjects with mRS score ≤ 1 at day 90 after administration
Measured: day 90
Secondary outcomes (7)
Modified Rankin Scale (mRS), with scores of 0-1 at day 12±2 and 30
Proportion of subjects with mRS score ≤ 1 at day 12±2 and 30 after administration
Measured: days 12±2 and 30
Modified Rankin Scale (mRS), with scores of 0-2 at days 12±2, 30 and 90
Proportion of subjects with mRS score ≤ 2 at day 12±2, 30, 90 after administration
Measured: days 12±2, 30 and 90
MRS Shift analysis
MRS shift analysis at day 90 after administration
Measured: day 90
National Institute of Health stroke scale (NIHSS) on day 12±2
Proportion of subjects with NIHSS score ≤ 1 or with ≥4 point reduction from baseline at day 12±2 after administration
Measured: days 12±2
National Institute of Health stroke scale (NIHSS) on day 12±2
Change in NIHSS score from baseline at day 12±2 after administration
Measured: days 12±2
Barthel index (BI) at Day 90
Proportion of subjects with BI score ≥95 at day 90 after administration
Measured: days 90
Barthel index (BI) at Day 90
Proportion of subjects with BI score ≥75 at day 90 after administration
Measured: days 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start22 Nov 2025
- Primary completion18 Oct 2026 (estimated)
- Study completion18 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279493
- Sponsor's protocol ID
- KPCXM18-C202
- Other IDs
- kyjtcrc
- Acronym
- KPCXM18
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 12 Dec 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase Ⅱb Clinical Trial to Evaluate the Efficacy and Safety of the KPCXM18 Injection at Different Doses in The Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07279493
- Acronym / sponsor ID
- KPCXM18 / KPCXM18-C202
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kunming Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 18 Oct 2026 (estimated)
- Study completion
- 18 Oct 2026 (estimated)
- First posted
- 12 Dec 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.
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
Detailed description
Trial Objectives:
The primary objective is to evaluate the efficacy of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
The secondary objective is to evaluate the safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke and based on the population pharmacokinetic analysis method, explore the PK characteristics of the KPCXM18 injection in patients with acute ischemic stroke, and provide a basis for the design of the phase III clinical study.
Trial Design:
This trial is a multicenter, randomized, double-blind, parallel, placebo-controlled design. The subjects will be randomly assigned to the low-dose group, the high-dose group, and the placebo group at a ratio of 1:1:1, with 100 subjects in each group, totaling 300 subjects. The treatment will be administered continuously for 12±2 days to explore the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose group （The KPCXM18 injection） | Experimental | Drug: The KPCXM18 injectionThe KPCXM18 injection (60 mg BID) |
| high-dose group （The KPCXM18 injection） | Experimental | Drug: The KPCXM18 injectionThe KPCXM18 injection (100 mg BID) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of the KPCXM18 injection( BID ) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age 18 to 80 years old (including 18 years old and 80 years old, based on the date of signing the informed consent form), male or female;
- 2.Diagnosed with acute ischemic stroke according to the " Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023 ";
- 3.During the screening process, it is required that the ischemic stroke should occur within 12 hours after the onset, and it is expected that the investigational drug can be started within 12 hours after the onset; note: The onset time is calculated from the time when the ischemic stroke symptoms appear, If the onset occurs during sleep, the time of onset should be considered as the last time the patient was observed to be normal;
- 4.Before intravenous thrombolysis, 6 points ≤ NIHSS score ≤ 24 points, and the sum of upper limb and lower limb score ≥2 points;
- 5.The patients who first attacked, or the patients who had a good prognosis after the last attacked , (mRS score was ≤1 before the onset of the disease );
Key exclusion criteria (18 listed)
- 1. Patients with intracranial hemorrhagic diseases confirmed by Imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, Traumatic cerebral hemorrhage, etc;
- 2. Patients who have received or plan to receive endovascular interventional treatment (including endovascular mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty and stenting) or patients with arteriovenous bridging therapy after this onset;
- 3. Patients with disturbance of consciousness (NIHSS score Ia>1 point);
- 4. Patient has a history of intracranial hemorrhage before;
- 5. Patient who have a history of epilepsy or who experienced epileptic symptoms during a stroke;
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 |
|---|---|---|
| The KPCXM18 injectionIntravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 12±2 days. | Drug | low-dose group （The KPCXM18 injection） |
| PlaceboIntravenous infusion twice a day with an interval of 12±2 hours for 12±2 days. | Drug | Placebo |
| The KPCXM18 injectionIntravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 12±2 days. | Drug | high-dose group （The KPCXM18 injection） |
Primary outcome
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
Time frame: day 90
Proportion of subjects with mRS score ≤ 1 at day 90 after administration
7 secondary outcomes
Modified Rankin Scale (mRS), with scores of 0-1 at day 12±2 and 30
Time frame: days 12±2 and 30
Modified Rankin Scale (mRS), with scores of 0-2 at days 12±2, 30 and 90
Time frame: days 12±2, 30 and 90
MRS Shift analysis
Time frame: day 90
National Institute of Health stroke scale (NIHSS) on day 12±2
Time frame: days 12±2
National Institute of Health stroke scale (NIHSS) on day 12±2
Time frame: days 12±2
Barthel index (BI) at Day 90
Time frame: days 90
Barthel index (BI) at Day 90
Time frame: days 90
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 12 Dec 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.
Yongjun Wang, MD principal investigator
Beijing Tiantan Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The KPCXM18 injection in people with Acute Ischemic Stroke, run by Kunming Pharmaceuticals, Inc. at 23 sites 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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 Duo Gao, bachelor (0871-68319868-3052, GAODUO5@kpc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90 (time frame: day 90). 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 12 Dec 2025.