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

NCT04898322 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-03-14

No results posted yet for this study

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

Interventions

DRUG

SY-005

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

DRUG

SY-005

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

DRUG

SY-005

10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days

DRUG

Placebo

Placebo

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-02
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898322 on ClinicalTrials.gov