KPCXM18 injection for acute ischemic stroke.

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 trial will try different doses of the KPCXM18 injection to see if it helps adults who have had an acute ischemic stroke when started within 12 hours of symptom onset.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Kunming Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 23 sites (Beijing, Beijing Municipality and 22 other locations)
• Trial ID: NCT07279493 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 2 trial that assigns 300 participants in a 1:1:1 ratio to low-dose, high-dose, or placebo groups. Treatment with KPCXM18 or placebo is given continuously for about 12 days (12 ± 2 days). The primary objective is to test efficacy at different doses for acute ischemic stroke, with secondary objectives including safety monitoring and population pharmacokinetic (PK) characterization. Results are intended to inform the design of a subsequent Phase 3 trial.

Who should consider this trial

Good fit: Adults aged 18 to 80 with a confirmed acute ischemic stroke per Chinese guidelines, who can start the investigational drug within 12 hours of symptom onset and have baseline NIHSS 6–24 with an upper- plus lower-limb score ≥2 and pre-stroke mRS ≤1.

Not a fit: Patients outside the 12-hour treatment window, with hemorrhagic stroke, baseline NIHSS outside 6–24, significant pre-stroke disability, or other contraindications are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, KPCXM18 could improve neurological recovery and reduce disability when given early after an acute ischemic stroke.

How similar studies have performed: KPCXM18 itself is novel, and prior pharmacologic neuroprotection approaches in acute ischemic stroke have shown mixed results overall, so benefit remains uncertain until confirmed by randomized trials.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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;
* 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.

Where this trial is running

Beijing, Beijing Municipality and 22 other locations

• Beijing Tiantan Hosptial，Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Recruiting)
• Hengshui People's Hospital — Hengshui, Hebei, China (Recruiting)
• Da Qing Long Nan Hospital — Daqing, Heilongjiang, China (Recruiting)
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China (Recruiting)
• The People's Hospital Of Anyang City — Anyang, Henan, China (Recruiting)
• Nanshi Hospital Of Nanyang — Nanyang, Henan, China (Recruiting)
• Nanyang Second General Hospital — Nanyang, Henan, China (Recruiting)
• The First Affiliated Hospital Of Nanyang Medical College — Nanyang, Henan, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Recruiting)
• Meihakou Central Hospital — Meihekou, Jilin, China (Recruiting)
• Affiliated Central Hospital Of Shenyang Medical College — Shenyang, Liaoning, China (Recruiting)
• The First People's Hospital Of Shenyang — Shenyang, Liaoning, China (Recruiting)
• The People's Hospital Of Liaoning Province — Shenyang, Liaoning, China (Recruiting)
• Yan'an University Xianyang Hospital — Xianyang, Shaanxi, China (Recruiting)
• First People's Hospital Of Tancheng — Linyi, Shandong, China (Recruiting)
• Linyi People's Hospital — Linyi, Shandong, China (Recruiting)
• Tengzhou Central People's Hospital — Tengzhou, Shandong, China (Recruiting)
• Sinopharm Tongmei General Hospital — Datong, Shanxi, China (Recruiting)
• Linfen Central Hospital — Linfen, Shanxi, China (Recruiting)
• Linfen People's Hospital — Linfen, Shanxi, China (Recruiting)
• Jiaxing Second Hospital — Jiaxing, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Yongjun Wang, MD — Beijing Tiantan Hospital
• Study coordinator: Duo Gao, bachelor

Conditions Acute Ischemic Stroke