Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke

NCT07279493 | Recruiting Phase 2

• 2 other identifiers: KPCXM18-C202kyjtcrc
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS), with scores of 0-1 at Day 90

  Proportion of subjects with mRS score ≤ 1 at day 90 after administration

  day 90

Secondary Outcomes (7)

• Modified Rankin Scale (mRS), with scores of 0-1 at day 12±2 and 30

  days 12±2 and 30

• Modified Rankin Scale (mRS), with scores of 0-2 at days 12±2, 30 and 90

  days 12±2, 30 and 90

• MRS Shift analysis

  day 90

• National Institute of Health stroke scale (NIHSS) on day 12±2

  days 12±2

• National Institute of Health stroke scale (NIHSS) on day 12±2

  days 12±2

Study Arms (3)

low-dose group （The KPCXM18 injection）

EXPERIMENTAL

The KPCXM18 injection (60 mg BID)

Drug: The KPCXM18 injection

high-dose group （The KPCXM18 injection）

EXPERIMENTAL

The KPCXM18 injection (100 mg BID)

Drug: The KPCXM18 injection

Placebo

PLACEBO COMPARATOR

Placebo of the KPCXM18 injection( BID )

Drug: Placebo

Interventions

Placebo DRUG

Intravenous infusion twice a day with an interval of 12±2 hours for 12±2 days.

Placebo

The KPCXM18 injection DRUG

Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 12±2 days.

low-dose group （The KPCXM18 injection）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• Diagnosed with acute ischemic stroke according to the " Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023 ";
• 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;
• Before intravenous thrombolysis, 6 points ≤ NIHSS score ≤ 24 points, and the sum of upper limb and lower limb score ≥2 points;
• 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 );
• The subject has received or plans to receive standard intravenous thrombolysis treatment after this onset;
• 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).

You may not qualify if:

• \. Patients with intracranial hemorrhagic diseases confirmed by Imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, Traumatic cerebral hemorrhage, etc;
• \. 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;
• \. Patients with disturbance of consciousness (NIHSS score Ia\>1 point);
• \. Patient has a history of intracranial hemorrhage before;
• \. Patient who have a history of epilepsy or who experienced epileptic symptoms during a stroke;
• \. 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;
• \. Patients with acute myocardial infarction, cardiac interventional therapy, or heart failure (grade III and IV according to NYHA) within the past 1 month;
• \. 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;
• \. Despite active antihypertensive therapy, hypertension remains uncontrolled: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg;
• Patients with severe liver function impairment, or ALT, AST \> 2.0× ULN;
• Patients with severe renal impairment, or serum creatinine \> 1.5× ULN;
• 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;
• 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;
• Patients with a history of major surgery within 1 month before screening;
• Patients with a history of drug abuse within 3 month before screening;

Sponsors & Collaborators

• Kunming Pharmaceuticals, Inc.: lead

Study Sites (23)

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

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duo Gao, bachelor

CONTACT

0871-68319868-3052; GAODUO5@kpc.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 12, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): October 18, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)