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drugset / Trial / NCT03388515

A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.

NCT03388515 ↗

Phase 1 Unknown 40 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.

Timeline

Start
2017-10-09
Primary completion
2019-07-30
Completion
2020-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegadricase Protein / enzyme biologic 1.5 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 3 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 6 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 12 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 24 mg Intravenous

Indications

gout