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 enrollmentJanuary 2, 2022

ConditionsSepsis

InterventionsSY-005 Placebo

DrugsSY-005 Placebo

Overview

Phase: Phase 2
Intervention: SY-005
Conditions: Sepsis
Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Enrollment: 96
Locations: 1
Primary Endpoint: Safety and Tolerability Parameters of SY-005
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2, 2022

End Date

July 1, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

2.5mg SY-005

Intervention: SY-005

5mg SY-005

Intervention: SY-005

10mg SY-005

Intervention: SY-005

Placebo

Intervention: Placebo

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)