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Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular Thrombectomy

2026년 5월 6일 업데이트: Shanghai QuietD Biotechnology Co., Ltd.

A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety, Pharmacokinetic Profile, and Efficacy of QD202 Injection in Patients With Acute Ischemic Stroke Undergoing Thrombolysis

This is a randomized, double-blinded, placebo-controlled study investigating the safety and efficacy of QD202 injection in patients with acute ischemic stroke undergoing thrombolysis excluding endovascular thrombectomy. Up to 120 male and female patients with acute ischemic stroke undergoing thrombolysis excluding endovascular thrombectomy will be dosed with QD202 injection or placebo as a 60 minute intravenous infusion after completion of the thrombolysis procedure on Day 1-5 of the study period. Subjects will undergo interim procedures at Day 7 or the day of discharge, Day 30, and end-of-study procedures on Day 90.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

120

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Guangdong
      • Meizhou, Guangdong, 중국
        • 모병
        • Meizhou People's Hospital
        • 연락하다:
        • 수석 연구원:
          • Tongguo Wei
    • Henan
      • Luoyang, Henan, 중국
        • 모병
        • Luoyang Central Hospital
        • 연락하다:
        • 수석 연구원:
          • Zhihui Duan
      • Nanyang, Henan, 중국
        • 모병
        • Nanshi Hospital of Nanyang
        • 연락하다:
        • 수석 연구원:
          • Zhaolong Peng
    • Jilin
      • Changchun, Jilin, 중국
        • 모병
        • Jilin Province People's Hospital
        • 연락하다:
        • 수석 연구원:
          • Zongshu Li
      • Meihekou, Jilin, 중국
        • 모병
        • Meihe Hospital the First Hospital of Jilin University
        • 수석 연구원:
          • Rui Wang
        • 연락하다:
    • Liaoning
      • Benxi, Liaoning, 중국
        • 모병
        • Benxi Central Hospital
        • 연락하다:
        • 수석 연구원:
          • Chengguang Song
      • Fuxin, Liaoning, 중국
        • 모병
        • General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
        • 연락하다:
        • 수석 연구원:
          • Lianqun Fu
      • Shengyang, Liaoning, 중국
        • 모병
        • Central Hospital Affiliated to Shenyang Medical College
        • 연락하다:
        • 수석 연구원:
          • Runhui Li
      • Shenyang, Liaoning, 중국
        • 모병
        • General Hospital of Northern Theater Command
        • 연락하다:
        • 수석 연구원:
          • Huisheng Chen
    • Shandong
      • Linyi, Shandong, 중국
        • 모병
        • Linyi People's Hospital
        • 수석 연구원:
          • Ziran Wang
        • 연락하다:
      • Weifang, Shandong, 중국
        • 모병
        • Weifang People's Hospital
        • 수석 연구원:
          • Li Zhou
        • 연락하다:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국
        • 모병
        • Shanghai Tenth People's Hospital
        • 연락하다:
        • 수석 연구원:
          • Jianliang Fu
      • Shanghai, Shanghai Municipality, 중국
        • 모병
        • Huashan Hospital Fudan University
        • 수석 연구원:
          • Liang Chen
        • 수석 연구원:
          • Jing Zhang
        • 연락하다:
        • 수석 연구원:
          • Xin Cheng
    • Shanxi
      • Linfen, Shanxi, 중국
        • 모병
        • Linfen Central Hospital
        • 수석 연구원:
          • Hongguo Dai
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 1. Subjects aged 18-85 years (inclusive), regardless of gender;
  • 2. Diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023);
  • 3. Time from stroke onset ≤ 24 hours (Onset time is calculated from the time stroke symptoms appear. If the stroke occurred during sleep or if the time of symptom onset cannot be accurately determined due to aphasia, impaired consciousness, or other reasons, the time the subject was last known to be normal should be used as the onset time);
  • 4. Pre-stroke modified Rankin Scale (mRS) score ≤ 1;
  • 5. After this event and prior to thrombolysis, NIHSS score is between 6 and 20 (inclusive), and the sum of scores on NIHSS Item 5 (motor arm) and Item 6 (motor leg) is ≥ 2;
  • 6. Planned for or have already undergone thrombolytic therapy;
  • 7. Female subjects of childbearing potential must have a negative serum pregnancy test and report no sexual activity within 14 days prior to screening. Subjects of childbearing potential (female or male) must agree to have no plans for pregnancy or sperm donation throughout the study period and are willing to use at least one effective method of contraception;
  • 8. The subject or their legal guardian voluntarily signs the informed consent form (ICF).

Exclusion Criteria:

  • 1. Allergy to any component of QD202 or the placebo.
  • 2. Intracranial hemorrhage detected on cranial computed tomography (CT), including hemorrhagic stroke (e.g., epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage) or hemorrhagic transformation of the current cerebral infarction. Subjects with mere microbleeds may be considered for inclusion at the investigator's discretion. Hemorrhage occurring after thrombolytic therapy, as a complication of the treatment and not classified as hemorrhagic stroke, may also be considered for inclusion at the investigator's discretion.
  • 3. Transient ischemic attack (TIA).
  • 4. Poorly controlled blood pressure despite active treatment (hypertension: systolic blood pressure ≥220 mmHg and/or diastolic blood pressure ≥120 mmHg; hypotension: systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤40 mmHg).
  • 5. Severe hyperglycemia/hypoglycemia: blood glucose ≥400 mg/dL (22.2 mmol/L) or ≤50 mg/dL (2.8 mmol/L).
  • 6. Heart rate <50 beats per minute and/or >120 beats per minute; second- or third-degree atrioventricular block, sinoatrial block, or sinus arrest; history within 6 months prior to screening of heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, or severe arrhythmia (including but not limited to rapid atrial fibrillation, atrial flutter, frequent premature beats, supraventricular or ventricular tachycardia).
  • 7. Severe impairment of consciousness after the current event and prior to thrombolysis: NIHSS level of consciousness (item 1a) score ≥2.
  • 8. History of severe psychiatric disorder or severe dementia.
  • 9. History of depression or anxiety, if the investigator deems participation in this clinical trial inappropriate.
  • 10. Subjects unsuitable for thrombolytic therapy, or those who have undergone or are planned to undergo endovascular interventional therapy.
  • 11. Use of therapeutic neuroprotective agents after stroke onset, including commercially available edaravone, edaravone dexborneol injection concentrate and sublingual tablets, ginkgolides, ginkgo diterpene lactone meglumine, nimodipine, gangliosides, citicoline, piracetam, oxiracetam, butylphthalide, cinepazide maleate injection, mouse nerve growth factor, potential neuroprotective Cerebrolysin (cerebroprotein hydrolysate), deproteinized calf blood extractives injection, ulinastatin, etc. (except mannitol used to reduce intracranial pressure).
  • 12. Concurrent malignancy diagnosed previously and currently undergoing anti-tumor therapy.
  • 13. History of severe systemic disease with an estimated life expectancy of <90 days.
  • 14. Diagnosed with severe active liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 times the upper limit of normal (ULN).
  • 15. Diagnosed with severe active kidney disease, renal insufficiency, or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
  • 16. Bleeding tendency, including platelet count (PLT) <75.0×10⁹/L, or history of major bleeding within 3 months prior to the current event.
  • 17. Major surgery within 4 weeks prior to screening, if the investigator assesses it may affect neurological function scores or 90-day survival.
  • 18. Alcohol dependence, drug abuse, substance addiction, or propensity for addiction.
  • 19. Participation in another clinical trial involving investigational drugs, vaccines, or medical devices within 3 months prior to screening.
  • 20. Any contraindication (e.g., cardiac pacemaker or other metal implants, claustrophobia) preventing or hindering CT or MRI examinations.
  • 21. Allergy to contrast agents.
  • 22. Chronic moderate to severe respiratory disease.
  • 23. Pregnant or breastfeeding women.
  • 24. Any other condition deemed by the investigator to make the subject unsuitable for participation in this clinical trial.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: QD202, 5 milligram (mg)
Participants will receive 100 mg of QD202 on Day 1 and 5 mg of QD202 daily from Day 2 to Day 5.
의약품: QD202
QD202 is a 19 amino acid peptide that consists of a 8 amino acid active domain and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier.
실험적: QD202, 10 milligram (mg)
Participants will receive 100 mg of QD202 on Day 1 and 10 mg of QD202 daily from Day 2 to Day 5.
의약품: QD202
QD202 is a 19 amino acid peptide that consists of a 8 amino acid active domain and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier.
위약 비교기: Placebo Comparator
Participants will receive matching placebo daily from Day 1 to Day 5.
의약품: Placebo
The placebo matches the investigational drug in appearance.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety and Tolerance
기간: Through study completion, an average of 90 days
To evaluate the safety and tolerability of intravenous infusion of QD202 in patients with acute ischemic stroke undergoing thrombolysis. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); clinically significant changes from baseline in laboratory tests, 12-lead electrocardiograms, vital signs, etc.
Through study completion, an average of 90 days

2차 결과 측정

결과 측정
측정값 설명
기간
Modified Rankin Scale (mRS)
기간: Day 30 and 90
Proportion of subjects achieving independent functioning as defined as a score of 0-1 or 0-2 on the mRS at Day 30 and Day 90.
Day 30 and 90
National Institutes of Health Stroke Scale (NIHSS)
기간: Day 7 or day of discharge
Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 7 or day of discharge.
Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
기간: Baseline up to Day 7 or day of discharge
Proportion of subjects achieving a good outcome as defined as a decrease of 4 or more points from baseline on the NIHSS at Day 7 or day of discharge.
Baseline up to Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
기간: Baseline up to Day 90
Change in NIHSS score from baseline to Day 7 or day of discharge, Day 30, and Day 90.
Baseline up to Day 90
Barthel Index (BI)
기간: Day 30 and 90
Proportion of subjects with a Barthel Index (BI) score ≥ 95 at Day 30 and Day 90 of treatment.
Day 30 and 90
The maximum plasma concentration (C[max])
기간: Baseline up to Day 5
The C[max] is the maximum observed plasma concentration and will be determined for QD202.
Baseline up to Day 5
Time to reach the maximum plasma concentration (T[max])
기간: Baseline up to Day 5
Time to reach maximum observed plasma concentration (T[max]) of QD202.
Baseline up to Day 5
Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t])
기간: Baseline up to Day 5
Area under the concentration-time curve from time zero to last time of quantifiable concentration of QD202.
Baseline up to Day 5
Terminal elimination half-life (t1/2)
기간: Baseline up to Day 5
Apparent terminal elimination half-life of QD202.
Baseline up to Day 5
Drug Clearance (CL)
기간: Baseline up to Day 5
The efficiency of irreversible elimination of QD202 from the body, typically measured in volume per time.
Baseline up to Day 5

기타 결과 측정

결과 측정
측정값 설명
기간
Cerebral Infarct Volume
기간: Baseline up to Day 7 or day of discharge
To measure the change in cerebral infarct volume from baseline in patients with acute ischemic stroke following intravenous infusion of QD202, as assessed by brain imaging.
Baseline up to Day 7 or day of discharge

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai QuietD Biotechnology Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 14일

기본 완료 (추정된)

2026년 8월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IST-003-202508
  • CTR20253923 (레지스트리 식별자: Center for Drug Evaluation, NMPA)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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