Sepsis
Conditions
Brief summary
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.
Interventions
DRUGSY-005
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
DRUGPlacebo
Placebo
Sponsors
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients are diagnosed with sepsis and receive study treatment within 48 hours * Sepsis-related Organ Failure Assessment（SOFA）score range from 2 to 13 * The informed consent form signed by the patient or the patient's legally acceptable representative 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: 1. Human immunodeficiency virus (HIV) infection 2. Patients undergoing active radiation or chemotherapy treatment within the past 3 months 3. Any organ or bone marrow transplant and related immunosuppressive therapy 4. High dose steroids (eg, \> 0.5 mg/kg prednisone or a steroid with equivalent activity, daily for a month) within 3 months before provision of written informed consent for the study * Patients with high bleeding risk: 1. Recent surgery \<72 hours, or a planned surgical procedure in the next 24h 2. Severe thrombocytopenia (\< 30 x 10\^9/L, before platelet transfusion) 3. Recent trauma \<72 hours 4. History of gastrointestinal bleeding or intracranial hemorrhage in the past 6 weeks. 5. Stroke or head injury in the past 3 months 6. On-going therapeutic anticoagulants that could not be interrupted (except prophylactic heparin treatment that can be continued） 7. Any history of Chronic liver disease with a Child score B or C 8. Any condition at risk of bleeding, as appreciated by the physician in charge of the patient * Severe anemia (hemoglobin \<5.9 g/dL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Parameters of SY-005 | From Day 0 to Day 28 | Number of patients with treatment-emergent adverse events over 28 days |
Secondary
| Measure | 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 |
| 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 Anti-drug Antibodies at Day7，Day14，Day28 | Baseline, Day7，Day14，Day28 |
| 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 IL-6 at Day 3，Day5 | Baseline, Day 3，Day5 |
Countries
China
Contacts
Primary ContactYi Yang
Outcome results
None listed