Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke
NCT ID: NCT07279493
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2025-11-22
2026-10-18
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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low-dose group （The KPCXM18 injection）
The KPCXM18 injection (60 mg BID)
The KPCXM18 injection
Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 12±2 days.
high-dose group （The KPCXM18 injection）
The KPCXM18 injection (100 mg BID)
The KPCXM18 injection
Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 12±2 days.
Placebo
Placebo of the KPCXM18 injection( BID )
Placebo
Intravenous infusion twice a day with an interval of 12±2 hours for 12±2 days.
Interventions
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The KPCXM18 injection
Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 12±2 days.
Placebo
Intravenous infusion twice a day with an interval of 12±2 hours for 12±2 days.
The KPCXM18 injection
Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 12±2 days.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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;
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Kunming Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yongjun Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Hengshui People's Hospital
Hengshui, Hebei, China
Da Qing Long Nan Hospital
Daqing, Heilongjiang, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The People's Hospital Of Anyang City
Anyang, Henan, China
Nanshi Hospital Of Nanyang
Nanyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
The First Affiliated Hospital Of Nanyang Medical College
Nanyang, Henan, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Meihakou Central Hospital
Meihekou, Jilin, China
Affiliated Central Hospital Of Shenyang Medical College
Shenyang, Liaoning, China
The First People's Hospital Of Shenyang
Shenyang, Liaoning, China
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China
First People's Hospital Of Tancheng
Linyi, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
Sinopharm Tongmei General Hospital
Datong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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kyjtcrc
Identifier Type: REGISTRY
Identifier Source: secondary_id
KPCXM18-C202
Identifier Type: -
Identifier Source: org_study_id
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