Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181

NCT02597114 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-09-25

No results posted yet for this study

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 an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug

Conditions

  • Mucopolysaccharidosis I

Interventions

DRUG

AGT-181

intravenous infusion over 3-4 hours

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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-03-19
Completion
2018-08-02

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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 NCT02597114 on ClinicalTrials.gov