NCT02371226

Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I

A Phase 1 Safety and Dose-Finding Study of a Human Insulin Receptor Monoclonal Antibody-Human Alpha-L-iduronidase (HIRMAb-IDUA) Fusion Protein, AGT-181 in Adult Patients With Mucopolysaccharidosis I (MPS I, Hurler Syndrome)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: ArmaGen, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is a safety and dose ranging study to obtain safety and exposure data, as well as information on the biological activity of the investigational drug.

Conditions

• Mucopolysaccharidosis I

Interventions

Type	Name	Description
DRUG	AGT-181 (HIRMAb-IDUA)	intravenous infusion over 3-4 hours

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-01-23
• Completion: 2017-02-01
• First posted: 2015-02-25
• Last updated: 2023-02-21

Locations

6 sites across 1 country: United States