drugset
drugset / Trial / NCT04217629

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

NCT04217629 ↗

Phase 1 Completed 96 enrolled Suzhou Yabao Pharmaceutical R&D Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2019-04-26
Primary completion
2019-10-05
Completion
2020-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject SY-005 Protein / enzyme biologic 0.75 mg Intravenous
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
Subject SY-005 Protein / enzyme biologic 15 mg Intravenous
Subject SY-005 Protein / enzyme biologic 20 mg Intravenous

Indications

infectious disease with sepsis