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ACTIVE NOT RECRUITING
NCT05422482
PHASE1

A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ

Sponsor: GC Biopharma Corp

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intracerebroventricular GC1123 in patients with MPS Ⅱ who have central nervous system involvement and are receiving treatment with intravenous drug

Official title: An Open-Label, Phase 1 and Extension Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ Who Have Central Nervous System Involvement and Are Receiving Treatment with Intravenous Drug

Key Details

Gender

All

Age Range

18 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2022-09-20

Completion Date

2027-06

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

GC1123

ICV-administered Hunterase, Idursulfase-ß

Locations (3)

Pusan National University Yangsan Hospital

Pusan, South Korea

Seoul National University

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea