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