drugset
drugset / Trial / NCT06582524

Pegzilarginase in Subjects <24 Months Old With Arginase 1 Deficiency

NCT06582524 ↗

Phase 3 Completed 3 enrolled Immedica Pharma AB
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicentre study to evaluate the safety, PK, and activity (PD) of weekly subcutaneous (SC) administration of pegzilarginase in subjects with ARG1-D who are \< 24 months of age. The study consists of a screening period of up to 4 weeks, a subsequent 12-week treatment period, and a safety follow-up period of 8 weeks.

Timeline

Start
2024-08-30
Primary completion
2025-06-17
Completion
2025-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegzilarginase Protein / enzyme biologic — Subcutaneous

Indications

arginase deficiency