Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular Thrombectomy (NCT07581210) is a Phase 2 interventional studying Acute Ischemic Stroke, sponsored by Shanghai QuietD Biotechnology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Ischemic Stroke and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Acute Ischemic Stroke subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form (ICF). Who Should NOT Join This Trial: - 1\. Allergy to any component of QD202 or the placebo. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

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.

DRUG

Placebo

The placebo matches the investigational drug in appearance.

Locations (14)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Meizhou People's Hospital
Meizhou, Guangdong, China
Luoyang Central Hospital
Luoyang, Henan, China
Nanshi Hospital of Nanyang
Nanyang, Henan, China
Jilin Province People's Hospital
Changchun, Jilin, China
Meihe Hospital the First Hospital of Jilin University
Meihekou, Jilin, China
Benxi Central Hospital
Benxi, Liaoning, China
General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
Fuxin, Liaoning, China
Central Hospital Affiliated to Shenyang Medical College
Shengyang, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Linyi People's Hospital
Linyi, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07581210), the sponsor (Shanghai QuietD Biotechnology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07581210 clinical trial studying?

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-stu… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07581210?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07581210?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07581210. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07581210. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.