drugset / Trial / NCT02643901

Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects

NCT02643901 ↗

Phase 1 Completed 26 enrolled Jiangsu T-Mab Biopharma Co.,Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.

Timeline

Start
2015-09
Primary completion
2016-10-10
Completion
2016-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GW003 Protein / enzyme biologic 150 ug/kg Subcutaneous
Subject GW003 Protein / enzyme biologic 300 ug/kg Subcutaneous
Subject GW003 Protein / enzyme biologic 500 ug/kg Subcutaneous
Subject GW003 Protein / enzyme biologic 650 ug/kg Subcutaneous
Subject GW003 Protein / enzyme biologic 850 ug/kg Subcutaneous

Indications