drugset / Trial / NCT01653444
Evaluate the Safety and Exploratory Efficacy of GC1119
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and exploratory efficacy of GC1119 (recombinant human α-galactosidase A) for enzyme replacement therapy in Fabry disease patients.
Timeline
- Start
- 2012-11
- Primary completion
- 2014-05
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GC1119 | Protein / enzyme biologic | 0.5 mg/kg | Intravenous |
| Subject | GC1119 | Protein / enzyme biologic | 1 mg/kg | Intravenous |