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

NCT04898322 | Unknown Phase 2

• 1 other identifier: SY005002
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability Parameters of SY-005

  Number of patients with treatment-emergent adverse events over 28 days

  From Day 0 to Day 28

Secondary Outcomes (14)

• 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

Study Arms (4)

2.5mg SY-005

EXPERIMENTAL

Drug: SY-005

5mg SY-005

EXPERIMENTAL

Drug: SY-005

10mg SY-005

EXPERIMENTAL

Drug: SY-005

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SY-005 DRUG

2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days

2.5mg SY-005

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Suzhou Yabao Pharmaceutical R&D Co., Ltd.: lead

Study Sites (1)

Zhongda Hospital，Affiliated to Southeast University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Yang

CONTACT

+86 025-83272015; yiyiyang2004@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 24, 2021
• Study Start: January 2, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

CN (1)