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> Record changed: 2026-10-13

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

NCT07279493

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

Participants

300

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

Lead sponsor

Kunming Pharmaceuticals, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

Start date

2025-11-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

Number of sites

23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Acronym**

KPCXM18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Dates

**Completion date**

2026-10-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**First posted**

2025-12-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Registry last updated**

2025-12-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Primary completion date**

2026-10-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Start date**

2025-11-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Size and sites

**Participants**

300

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Planned participants**

300

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Randomisation ratio**

1:1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Number of sites**

23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Lead sponsor**

Kunming Pharmaceuticals, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Identifiers

**Registry ID**

NCT07279493

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**ClinicalTrials.gov ID**

NCT07279493

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Outcomes

### Primary outcomes

1. Modified Rankin Scale (mRS), with scores of 0-1 at Day 90  
Timeframe: day 90  
Proportion of subjects with mRS score ≤ 1 at day 90 after administration

### Secondary outcomes

1. Modified Rankin Scale (mRS), with scores of 0-1 at day 12±2 and 30  
Timeframe: days 12±2 and 30  
Proportion of subjects with mRS score ≤ 1 at day 12±2 and 30 after administration
2. Modified Rankin Scale (mRS), with scores of 0-2 at days 12±2, 30 and 90  
Timeframe: days 12±2, 30 and 90  
Proportion of subjects with mRS score ≤ 2 at day 12±2, 30, 90 after administration
3. MRS Shift analysis  
Timeframe: day 90  
MRS shift analysis at day 90 after administration
4. National Institute of Health stroke scale (NIHSS) on day 12±2  
Timeframe: days 12±2  
Proportion of subjects with NIHSS score ≤ 1 or with ≥4 point reduction from baseline at day 12±2 after administration
5. National Institute of Health stroke scale (NIHSS) on day 12±2  
Timeframe: days 12±2  
Change in NIHSS score from baseline at day 12±2 after administration
6. Barthel index (BI) at Day 90  
Timeframe: days 90  
Proportion of subjects with BI score ≥95 at day 90 after administration
7. Barthel index (BI) at Day 90  
Timeframe: days 90  
Proportion of subjects with BI score ≥75 at day 90 after administration

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

80 Years

**Healthy volunteers**

No

### 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Sites

- Beijing Tiantan Hosptial，Capital Medical UniversityBeijing, ChinaRecruiting
- Shenzhen Second People's HospitalShenzhen, ChinaRecruiting
- Cangzhou Central HospitalCangzhou, ChinaRecruiting
- Hengshui People's HospitalHengshui, ChinaRecruiting
- Da Qing Long Nan HospitalDaqing, ChinaRecruiting
- Daqing Oilfield General HospitalDaqing, ChinaRecruiting
- The People's Hospital Of Anyang CityAnyang, ChinaRecruiting
- Nanshi Hospital Of NanyangNanyang, ChinaRecruiting
- Nanyang Second General HospitalNanyang, ChinaRecruiting
- The First Affiliated Hospital Of Nanyang Medical CollegeNanyang, ChinaRecruiting
- Xuzhou Central HospitalXuzhou, ChinaRecruiting
- Meihakou Central HospitalMeihekou, ChinaRecruiting
- Affiliated Central Hospital Of Shenyang Medical CollegeShenyang, ChinaRecruiting
- The First People's Hospital Of ShenyangShenyang, ChinaRecruiting
- The People's Hospital Of Liaoning ProvinceShenyang, ChinaRecruiting
- Yan'an University Xianyang HospitalXianyang, ChinaRecruiting
- First People's Hospital Of TanchengLinyi, ChinaRecruiting
- Linyi People's HospitalLinyi, ChinaRecruiting
- Tengzhou Central People's HospitalTengzhou, ChinaRecruiting
- Sinopharm Tongmei General HospitalDatong, ChinaRecruiting
- Linfen Central HospitalLinfen, ChinaRecruiting
- Linfen People's HospitalLinfen, ChinaRecruiting
- Jiaxing Second HospitalJiaxing, ChinaRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## References

### Other registry identifiers

- kyjtcrc

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07279493)

## Related records

### Drugs (1)

- [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md)

### Lead sponsors (1)

- [Kunming Pharmaceuticals, Inc.](https://trialight.com/data/company/kunming-pharmaceuticals-inc-b996c315-db49-4247-bc6d-4a58cf528aa6.md)

### Conditions (2)

- [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md)
- [Transient ischemic attack](https://trialight.com/data/condition/transient-ischemic-attack-4355dfad-752a-55bb-8d3e-cd43c9c8144b.md) Primary condition

---

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