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

6 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yichuan Cai
  • Número de teléfono: 86-13524815449
  • Correo electrónico: caiyc@quietdbio.com

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: 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.
Experimental: 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.
Droga: 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.
Comparador de placebos: Placebo Comparator
Participants will receive matching placebo daily from Day 1 to Day 5.
Droga: Placebo
The placebo matches the investigational drug in appearance.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety and Tolerance
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Modified Rankin Scale (mRS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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)
Periodo de tiempo: Baseline up to Day 5
Apparent terminal elimination half-life of QD202.
Baseline up to Day 5
Drug Clearance (CL)
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cerebral Infarct Volume
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shanghai QuietD Biotechnology Co., Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de octubre de 2025

Finalización primaria (Estimado)

1 de agosto de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IST-003-202508
  • CTR20253923 (Identificador de registro: Center for Drug Evaluation, NMPA)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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