A Study of GC1111 in Hunter Syndrom Patients

Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients

The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients

Inclusion Criteria:

• Patients diagnosed with Hunter syndrome
• Male at the age of ≥ 5
• Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator.
• Voluntarily signed written informed consent to participation in this study
• Consent to contraception

Exclusion Criteria:

• Prior treatment with iduronate-2-sulfatase ERT
• History of bronchotomy, bone marrow trasplanation, or cord blood transplanation.
• Known hypersensitivity reactions to any of the components of the invetigational product
• Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study.
• Unable to perform 6-MWT.
• Female