drugset / Trial / NCT04047394

A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers

NCT04047394

Phase 1 Unknown 33 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.
NaSequentialOpen-labelTreatment

Summary

To evaluate the safety, tolerability, PK and preliminary PD of SSS11 for injection in chinese healthy adult volunteers.

Timeline

Start
2019-10-22
Primary completion
2022-10-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegadricase Protein / enzyme biologic 2 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 3 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 4.5 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 6 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 8 mg Intravenous
Subject Pegadricase Protein / enzyme biologic 10 mg Intravenous

Indications