Clinical Trial: Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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 Muc
Brief 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.
Detailed Summary:
Sponsor: ArmaGen, Inc
Current Primary Outcome: Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: eight weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- plasma pharmacokinetic parameters (maximal concentration, half-life, area under the curve, mean residence time, volume of distribution and clearance of AGT-181) [ Time Frame: 8 weeks ]
- change in urinary or plasma glycosaminoglycans (GAGs) [ Time Frame: 8 weeks ]
- change in liver size [ Time Frame: 8 weeks ]
- change in spleen size [ Time Frame: 8 weeks ]
- change in levels of heparan sulfate and dermatan sulfate in the cerebrospinal fluid [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: ArmaGen, Inc
Dates:
Date Received: February 19, 2015
Date Started: July 2015
Date Completion: June 2017
Last Updated: March 3, 2017
Last Verified: March 2017
