Acute Ischemic StrokePhase 2NCT07581210
Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular Thrombectomy
A Phase 2 study testing QD202 in people with Acute Ischemic Stroke, run by Shanghai QuietD Biotechnology Co., Ltd. at 14 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- QD202
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 14 sitesChina
- Study dates
- 14 Oct 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Benxi Central Hospital
Benxi, Liaoning
Chengguang Song, scg2011@163.com
Chengguang Song
- Recruiting
Jilin Province People's Hospital
Changchun, Jilin
Zongshu Li, 121824864@qq.com
Zongshu Li
- Recruiting
General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
Fuxin, Liaoning
Lianqun Fu, fulianqun6886@163.com
Lianqun Fu
- Recruiting
Linfen Central Hospital
Linfen, Shanxi
Hongguo Dai, daihongguo3199@163.com
Hongguo Dai
- Recruiting
Linyi People's Hospital
Linyi, Shandong
Ziran Wang, wzr0806@163.com
Ziran Wang
- Recruiting
Luoyang Central Hospital
Luoyang, Henan
Zhihui Duan, duanzhihui76@126.com
Zhihui Duan
- Recruiting
Meihe Hospital the First Hospital of Jilin University
Meihekou, Jilin
Rui Wang, wangrui2323@163.com
Rui Wang
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong
Tongguo Wei, 13723638883@139.com
Tongguo Wei
- Recruiting
Nanshi Hospital of Nanyang
Nanyang, Henan
Zhaolong Peng, 18530696963@163.com
Zhaolong Peng
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality
Xin Cheng, chengxin@fudan.edu.cn
Xin Cheng
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Jianliang Fu, fujianliang@163.com
Jianliang Fu
- Recruiting
Central Hospital Affiliated to Shenyang Medical College
Shengyang, Liaoning
Runhui Li, Lirh710717@163.com
Runhui Li
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning
Huisheng Chen, chszh@aliyun.com
Huisheng Chen
- Recruiting
Weifang People's Hospital
Weifang, Shandong
Li Zhou, weifangzhou003@163.com
Li Zhou
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- QD202, Placebo
- Keywords
- Neuroprotective Agent, Thrombolysis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QD202Drug
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.
PlaceboDrug
The placebo matches the investigational drug in appearance.
| Study group | Role | What they receive |
|---|---|---|
| QD202, 5 milligram (mg) | Experimental | Participants will receive 100 mg of QD202 on Day 1 and 5 mg of QD202 daily from Day 2 to Day 5. Receives: Drug: QD202 |
| QD202, 10 milligram (mg) | Experimental | Participants will receive 100 mg of QD202 on Day 1 and 10 mg of QD202 daily from Day 2 to Day 5. Receives: Drug: QD202 |
| Placebo Comparator | Placebo comparator | Participants will receive matching placebo daily from Day 1 to Day 5. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerance
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.
Measured: Through study completion, an average of 90 days
Secondary outcomes (10)
Modified Rankin Scale (mRS)
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.
Measured: Day 30 and 90
National Institutes of Health Stroke Scale (NIHSS)
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.
Measured: Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
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.
Measured: Baseline up to Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
Change in NIHSS score from baseline to Day 7 or day of discharge, Day 30, and Day 90.
Measured: Baseline up to Day 90
Barthel Index (BI)
Proportion of subjects with a Barthel Index (BI) score ≥ 95 at Day 30 and Day 90 of treatment.
Measured: Day 30 and 90
The maximum plasma concentration (C[max])
The C[max] is the maximum observed plasma concentration and will be determined for QD202.
Measured: Baseline up to Day 5
Time to reach the maximum plasma concentration (T[max])
Time to reach maximum observed plasma concentration (T[max]) of QD202.
Measured: Baseline up to Day 5
Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t])
Area under the concentration-time curve from time zero to last time of quantifiable concentration of QD202.
Measured: Baseline up to Day 5
Terminal elimination half-life (t1/2)
Apparent terminal elimination half-life of QD202.
Measured: Baseline up to Day 5
Drug Clearance (CL)
The efficiency of irreversible elimination of QD202 from the body, typically measured in volume per time.
Measured: Baseline up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start14 Oct 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai QuietD Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581210
- Sponsor's protocol ID
- IST-003-202508
- Other IDs
- CTR20253923
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07581210
- Acronym / sponsor ID
- IST-003-202508
- Conditions
- Acute Ischemic Stroke
- Keywords
- Neuroprotective Agent, Thrombolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai QuietD Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QD202, 5 milligram (mg) | Experimental | Drug: QD202Participants will receive 100 mg of QD202 on Day 1 and 5 mg of QD202 daily from Day 2 to Day 5. |
| QD202, 10 milligram (mg) | Experimental | Drug: QD202Participants will receive 100 mg of QD202 on Day 1 and 10 mg of QD202 daily from Day 2 to Day 5. |
| Placebo Comparator | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo daily from Day 1 to Day 5. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QD202QD202 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 | QD202, 10 milligram (mg), QD202, 5 milligram (mg) |
| PlaceboThe placebo matches the investigational drug in appearance. | Drug | Placebo Comparator |
Primary outcome
Safety and Tolerance
Time frame: 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.
10 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: Day 30 and 90
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Baseline up to Day 7 or day of discharge
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Baseline up to Day 90
Barthel Index (BI)
Time frame: Day 30 and 90
The maximum plasma concentration (C[max])
Time frame: Baseline up to Day 5
Time to reach the maximum plasma concentration (T[max])
Time frame: Baseline up to Day 5
Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t])
Time frame: Baseline up to Day 5
Terminal elimination half-life (t1/2)
Time frame: Baseline up to Day 5
Drug Clearance (CL)
Time frame: Baseline up to Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QD202 in people with Acute Ischemic Stroke, run by Shanghai QuietD Biotechnology Co., Ltd. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yichuan Cai (86-13524815449, caiyc@quietdbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerance (time frame: Through study completion, an average of 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.