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Single-dose/Multiple-doses Incremental Intravenous Injection of SY-005 （Recombinant Human Annexin A5）in Healthy Subjects

Sepsis Clinical Trial

Official title:
Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-005 After Single-dose/Multiple-doses Incremental Intravenous Injection in Healthy Subjects

Clinical Trial Summary

This is a single-dose/multiple-doses incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic study of a single-dose/multiple-doses incremental intravenous injection of SY-005（recombinant human annexin A5） in healthy subjects. Six sigle-dose group trials are planned: 0.75mg, 2.5mg, 5mg, 10mg, 15mg,and 20mg and three multiple-doses groups are planned: 5mg, 10mg and 20mg. Single-dose groups are planned to enroll 64 subjects and multiple-doses groups are planned to enroll 30 subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04217629
Study type Interventional
Source Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date April 26, 2019
Completion date August 19, 2020
View Details
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