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Safety and Dose Ranging Study of Insulin Receptor MoAb-IDS Fusion Protein in Patients With Hunter Syndrome

NCT02262338 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-09-18

No results posted yet for this study

Summary

AGT-182 is a fusion protein containing idursulfase 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 II

Interventions

DRUG

AGT-182

Recombinant HIRMAb-IDS

Sponsors & Collaborators

  • ArmaGen, Inc

    lead INDUSTRY

Principal Investigators

  • Patrice Rioux, MD PhD · ArmaGen, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-03-27
Completion
2017-03-27

Countries

  • United States
  • Germany
  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02262338 on ClinicalTrials.gov