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This Phase IIa Randomized, Double-blind, Parallel Group, Placebo-controlled, multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Intravenous Injection of SY-005(recombinant human annexin A5) in Sepsis Subjects. 96 patients will be entered into the study and randomised in a 1:1:1:1 ratio to receive SY-005 2.5mg or SY-005 5mg or SY-005 10mg or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5mg SY-005 | Experimental |
| |
| 5mg SY-005 | Experimental |
| |
| 10mg SY-005 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-005 | Drug | 2.5mg of SY-005 for each dose,doses to be given every 12 hours over a period of 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Parameters of SY-005 | Number of patients with treatment-emergent adverse events over 28 days | From Day 0 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 1, Day3, Day5, Day7 | Baseline, Day 1, Day3, Day5, Day7 | |
| Vasopressin Free Days From Day 0 to Day 28 | From Day 0 to Day 28 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Pregnant or breastfeeding women ; Women of childbearing potential (WOCBP) could not take effective method of contraception
Moribund, and death is considered imminent within 24 hours or patient expected survival time is less than 6 months due to the underlying disease
Absolute neutrophil count (ANC) <0.5 x 10^9/L
New York Heart Association (NYHA) classification IV
Patient with end-stage lung disease
eGFR <60ml/min
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3.0 times the upper limit of normal (ULN)
Immunosuppressed patients with following situations:
Patients with high bleeding risk:
Severe anemia (hemoglobin <5.9 g/dL)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang | Contact | +86 025-83272015 | yiyiyang2004@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital,Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| SY-005 | Drug | 5mg of SY-005 for each dose,doses to be given every 12 hours over a period of 5 days |
|
| SY-005 | Drug | 10mg of SY-005 for each dose,doses to be given every 12 hours over a period of 5 days |
|
| Placebo | Drug | Placebo |
|
| Assessment of ICU-Free Days From Day 0 to Day 28 | From Day 0 to Day 28 |
| Ventilator-Free Days From Day 0 to Day 28 | From Day 0 to Day 28 |
| 7-Day and 28-Day Mortality | Over 7/28 Days Following First Dose |
| Change From Baseline in IL-1β at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in IL-6 at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in Procalcitonin at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in Prothrombin Time at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in Thrombin Time at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in Activated Partial Thromboplastin Time at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in Fibrinogen at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in Chemokine(C-C motif) Ligand 2 at Day 3,Day5 | Baseline, Day 3,Day5 |
| Change From Baseline in Anti-drug Antibodies at Day7,Day14,Day28 | Baseline, Day7,Day14,Day28 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |