drugset / Trial / NCT02371226
Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-07
- Primary completion
- 2017-01-23
- Completion
- 2017-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VALANAFUSP ALFA | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | VALANAFUSP ALFA | Protein / enzyme biologic | 3 mg/kg | Intravenous |
| Subject | VALANAFUSP ALFA | Protein / enzyme biologic | 6 mg/kg | Intravenous |
| Subject | VALANAFUSP ALFA | Protein / enzyme biologic | 9 mg/kg | Intravenous |