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This study is a multi-center, randomized, double-blind, double-dummy, placebo-controlled, single dose escalation study aimed at evaluating the overall safety, tolerability, and preliminary efficacy of HRS-7450 in patients with acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7450 | Experimental |
| |
| 0.9% sodium chloride injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7450 | Drug | HRS-7450 Injection |
| |
| 0.9% sodium chloride injection |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Intracranial Hemorrhage within 36 hours after the start of administration, The incidence of sICH | within 36 hours after the start of administration |
| Measure | Description | Time Frame |
|---|---|---|
| 7 day mortality rate after administration | within 7days after the start of administration | |
| The incidence of sICH 7 days after administration | within 7days after the start of administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat sen University | Guangzhou | Guangdong | 510062 | China |
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Multi-center, randomized, double-blind and double simulated, placebo controlled, single dose escalation
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| Drug |
0.9% sodium chloride injection |
|
| The incidence of ICH 7 days after administration |
| within 7days after the start of administration |
| The incidence of systemic bleeding 7 days after administration | within 7days after the start of administration |
| Effective reperfusion rate measured by 24-hour PWI or CTP | within 24 hours after the start of administration |
| 24-hour MRA or CTA measurement of vascular reperfusion rate | within 24 hours after the start of administration |
| Infarct core volume measured by CT or MRI at 5-7 days | within 5-7days after the start of administration |
| 24-hour NIHSS score change | within 24 hours after the start of administration |
| 24-hour good response rate (NIHSS score reduction greater than 8 points, or NIHSS score 0-1) | within 24 hours after the start of administration |
| 7 day NIHSS score change | within 7days after the start of administration |
| 7 day good response rate (NIHSS score reduction greater than 8 points, or NIHSS score 0-1) | within 7days after the start of administration |
| 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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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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