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Clinical trial

A Phase 1/2/3 First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of a Single Intravenous (IV) Administration of ECUR-506 in Males Less Than 9 Months of Age With Genetically Confirmed Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

NCT06255782 is registered in ClinicalTrials.gov with iECURE, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1/2/3 First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of a Single Intravenous (IV) Administration of ECUR-506 in Males Less Than 9 Months of Age With Genetically Confirmed Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency
Lead sponsor
iECURE, Inc.
Phase
Phase 3
Overall status
Active, not recruiting
Start date
April 8, 2024
Completion date
December 31, 2027
Enrollment
20 (estimated)
Sites
12

Conditions

As the registry lists them; a condition with its own page is linked.

ornithine carbamoyltransferase deficiency (disorder), ornithine transcarbamylase deficiency, ornithine transcarbamylase deficiency disease, urea cycle disorders, inborn