Acute Ischemic Stroke
Conditions
Keywords
Neuroprotective Agent, Thrombolysis
Brief summary
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.
Interventions
DRUGQD202
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.
DRUGPlacebo
The placebo matches the investigational drug in appearance.
Sponsors
Shanghai QuietD Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 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. |
| National Institutes of Health Stroke Scale (NIHSS) | 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. |
| Barthel Index (BI) | Day 30 and 90 | Proportion of subjects with a Barthel Index (BI) score ≥ 95 at Day 30 and Day 90 of treatment. |
| The maximum plasma concentration (C[max]) | Baseline up to Day 5 | The C\[max\] is the maximum observed plasma concentration and will be determined for QD202. |
| Time to reach the maximum plasma concentration (T[max]) | Baseline up to Day 5 | Time to reach maximum observed plasma concentration (T\[max\]) of QD202. |
| Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]) | Baseline up to Day 5 | Area under the concentration-time curve from time zero to last time of quantifiable concentration of QD202. |
| Terminal elimination half-life (t1/2) | Baseline up to Day 5 | Apparent terminal elimination half-life of QD202. |
| Drug Clearance (CL) | Baseline up to Day 5 | The efficiency of irreversible elimination of QD202 from the body, typically measured in volume per time. |
Countries
China
Contacts
CONTACTYichuan Cai
Outcome results
None listed