NCT04898322

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-02
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2021-05-24
• Last updated: 2022-03-14

Locations

1 site across 1 country: China