Evaluate the Safety and Exploratory Efficacy of GC1119

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation

Criteria

Inclusion Criteria:

• Subjects with a current diagnosis of Fabry's disease

• Plasma α-gal activity of ≤ 1.5mnol/hr/ml and have a mutation in α-galactosidase A gene

• Males ≥ 16 years old

• Subjects capable of performing this clinical trial in an appropriate manner

• Informed consent form voluntarily signed by the subject(or his legally acceptable representative if the subject is under 20 years old) to participation in the study

• Agreement to contraception during the study period

Exclusion Criteria:

• Serum creatinine > 2.5mg/dl

• Subjects have a plan to kidney transplantation

• Subjects have undergone kidney transplantation

• Subjects are currently on dialysis

• Subjects have a clinically significant organic disease(cardiovascular, hepatic, pulmonary, neurologic, or renal disease)that in the opinion of the investigator would preclude participation in the trial

• Known life-threatening hypersensitivity(anaphylactic reaction) to α-galactosidase

• Treatment with another investigational product within 30days from the administration of study drug dosing or plans to be treated with another investigational product during the study period

• Known hypersensitivity to any of the ingredients of study drug(including excipients)

• Subjects need the medication of prohibited drug

• Alcoholism or drug addiction