drugset / Trial / NCT05676853
A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, multicenter study to evaluate the safety of weekly SC administration of pegzilarginase over 12 months in subjects with ARG1-D. The study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a Safety Follow-Up Visit 2 weeks after the last treatment.
Timeline
- Start
- 2023-04-04
- Primary completion
- 2023-04-27
- Completion
- 2023-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegzilarginase | Protein / enzyme biologic | — | Subcutaneous |