NCT04898322UnknownPhase 2
A 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 in Sepsis Subjects
Suzhou Yabao Pharmaceutical R&D Co., Ltd.1 site in 1 country96 target enrollmentStarted: January 2, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability Parameters of SY-005
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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)
Arms & Interventions
2.5mg SY-005
Experimental
Intervention: SY-005 (Drug)
5mg SY-005
Experimental
Intervention: SY-005 (Drug)
10mg SY-005
Experimental
Intervention: SY-005 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety and Tolerability Parameters of SY-005
Time Frame: From Day 0 to Day 28
Number of patients with treatment-emergent adverse events over 28 days
Secondary Outcomes
- 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)
- 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 Activated Partial Thromboplastin Time at Day 3，Day5(Baseline, Day 3，Day5)
- 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)
- 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 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)
Investigators
Study Sites (1)
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