SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis

Phase 2

• Conditions: Sepsis
• Interventions: Drug: SY-005; Drug: Placebo

• Registration Number: NCT04898322
• Lead Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-24
• Study Start: 2022-01-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-27
• Last Update Posted: 2022-03-14
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10mg SY-005	SY-005	-
Placebo	Placebo	-
2.5mg SY-005	SY-005	-
5mg SY-005	SY-005	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Zhongda Hospital，Affiliated to Southeast University; 🇨🇳 Nanjing, Jiangsu, China