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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20253923 | Registry Identifier | Center for Drug Evaluation, NMPA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Placebo Comparator | Placebo Comparator | Participants will receive matching placebo daily from Day 1 to Day 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QD202 | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 30 and 90 |
| National Institutes of Health Stroke Scale (NIHSS) |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Infarct Volume | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yichuan Cai | Contact | 86-13524815449 | caiyc@quietdbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meizhou People's Hospital | Recruiting | Meizhou | Guangdong | China |
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| Placebo | Drug | The placebo matches the investigational drug in appearance. |
|
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) | 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) | 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) | 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]) | 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]) | 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]) | 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) | Apparent terminal elimination half-life of QD202. | Baseline up to Day 5 |
| Drug Clearance (CL) | The efficiency of irreversible elimination of QD202 from the body, typically measured in volume per time. | Baseline up to Day 5 |
| Luoyang Central Hospital | Recruiting | Luoyang | Henan | China |
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| Nanshi Hospital of Nanyang | Recruiting | Nanyang | Henan | China |
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| Jilin Province People's Hospital | Recruiting | Changchun | Jilin | China |
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| Meihe Hospital the First Hospital of Jilin University | Recruiting | Meihekou | Jilin | China |
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| Benxi Central Hospital | Recruiting | Benxi | Liaoning | China |
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| General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group | Recruiting | Fuxin | Liaoning | China |
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| Central Hospital Affiliated to Shenyang Medical College | Recruiting | Shengyang | Liaoning | China |
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| General Hospital of Northern Theater Command | Recruiting | Shenyang | Liaoning | China |
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| Linyi People's Hospital | Recruiting | Linyi | Shandong | China |
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| Weifang People's Hospital | Recruiting | Weifang | Shandong | China |
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| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Linfen Central Hospital | Recruiting | Linfen | Shanxi | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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