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
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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