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The sponsor decided to suspend the process
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This Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15mg SY-007/ Placebo Repeat Dose | Experimental | Intravenous infusion of 15mg SY-007 or placebo twice a day for seven consecutive days. |
|
| 30mg SY-007/ Placebo Repeat Dose | Experimental | Intravenous infusion of 30mg SY-007 or placebo twice a day for seven consecutive days. |
|
| 60mg SY-007/ Placebo Repeat Dose | Experimental | Intravenous infusion of 60mg SY-007 or placebo twice a day for seven consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-007/ Placebo 15mg | Drug | 15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerance of SY-007 | Number of patients with treatment-emergent adverse events and number of patients who died over 90 days | From Day 0 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of SY-007 | Peak Plasma Concentration (Cmax) | From Day 0 to Day 7 |
| Pharmacokinetics of SY-007 | Area under the plasma concentration versus time curve (AUC) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | 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 |
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| SY-007/ Placebo 30mg | Drug | 30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days. |
|
| SY-007/ Placebo 60mg | Drug | 60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days. |
|
| From Day 0 to Day 7 |
| Pharmacokinetics of SY-007 | Time to Cmax (Tmax) | From Day 0 to Day 7 |
| Pharmacokinetics of SY-007 | Terminal half life (T½) | From Day 0 to Day 7 |
| Pharmacokinetics of SY-007 | Clearance (CL) | From Day 0 to Day 7 |
| Pharmacokinetics of SY-007 | Volume of distribution | From Day 0 to Day 7 |
| Percentage of Participants With Excellent Outcome in Modified Rankin Scale(mRS) Score at Day 8, Day30, Day60, Day90 | Excellent mRS is defined as mRS score of 0 or 1 | Day 8, Day30, Day60, Day90 |
| Modified Rankin Scale Score at Day 8, Day30, Day60, Day90 | Modified Rankin Scale Score range from 0 to 5,higher score mean a worse outcome. | Day 8, Day30, Day60, Day90 |
| Percentage of Participants With National Institute of Health Stroke Scale (NIHSS) range from 0 to 1 at Day 8, Day30 | Day 8, Day30 |
| Change From Baseline in NIHSS Score at Day 8, Day30 range from 0 to 1 at Day 8, Day30 | Day 8, Day30 |
| Percentage of Participants With Excellent Outcome in Barthel index (BI) Score at Day 8, Day30, Day60, Day 90 | Excellent BI outcome is defined as a score of >=95. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility. | Day 8, Day30, Day60, Day 90 |
| Change of Cerebral infarction volume before and after treatment | Baseline, Day 8, Day30 |
| Immunogenicity of SY-007 | Anti-Drug antibody evaluation | From Day 0 to Day 30 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |