SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 2.5mg SY-005
|
Drug: SY-005
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
|
| Experimental: 5mg SY-005
|
Drug: SY-005
5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
|
| Experimental: 10mg SY-005
|
Drug: SY-005
10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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]
Eligibility Criteria
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:
-
Human immunodeficiency virus (HIV) infection
-
Patients undergoing active radiation or chemotherapy treatment within the past 3 months
-
Any organ or bone marrow transplant and related immunosuppressive therapy
-
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:
-
Recent surgery <72 hours, or a planned surgical procedure in the next 24h
-
Severe thrombocytopenia (< 30 x 10^9/L, before platelet transfusion)
-
Recent trauma <72 hours
-
History of gastrointestinal bleeding or intracranial hemorrhage in the past 6 weeks.
-
Stroke or head injury in the past 3 months
-
On-going therapeutic anticoagulants that could not be interrupted (except prophylactic heparin treatment that can be continued）
-
Any history of Chronic liver disease with a Child score B or C
-
Any condition at risk of bleeding, as appreciated by the physician in charge of the patient
- Severe anemia (hemoglobin <5.9 g/dL)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongda Hospital，Affiliated to Southeast University | Nanjing | Jiangsu | China |
Sponsors and Collaborators
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SY005002