drugset / Trial / NCT04898322
SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2022-01-02
- Primary completion
- 2023-07-01
- Completion
- 2023-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SY-005 | Protein / enzyme biologic | 2.5 mg | Intravenous |
| Subject | SY-005 | Protein / enzyme biologic | 5 mg | Intravenous |
| Subject | SY-005 | Protein / enzyme biologic | 10 mg | Intravenous |