Evaluate the Safety and Exploratory Efficacy of GC1119
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)