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Monoclonal Antibodies

Cohort 1 for Hurler Syndrome

Phase 1
Waitlist Available
Research Sponsored by ArmaGen, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

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

Eligible Conditions
  • Hurler Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eight weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and eight weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events as a measure of safety and tolerability
Secondary outcome measures
change in levels of heparan sulfate and dermatan sulfate in the cerebrospinal fluid
change in liver size
change in spleen size
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
6-9 mg/kg AGT-181 (HIRMAb-IDUA) administered once weekly x 8 weeks
Group II: Cohort 2Experimental Treatment1 Intervention
3 mg/kg AGT-181 (HIRMAb-IDUA) administered once weekly x 8 weeks
Group III: Cohort 1Experimental Treatment1 Intervention
1 mg/kg AGT-181 (fusion protein of anti-human insulin receptor monoclonal antibody and alpha-L-iduronidase; HIRMAb-IDUA) administered once weekly x 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benzalkonium
FDA approved

Find a Location

Who is running the clinical trial?

ArmaGen, IncLead Sponsor
4 Previous Clinical Trials
49 Total Patients Enrolled
Patrice Rioux, MD PhDStudy DirectorArmaGen, Inc
2 Previous Clinical Trials
9 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I
2015. "Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02371226.
~0 spots leftby Apr 2025
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