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Study identifier: NCT06255782 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency

Condition: Ornithine Transcarbamylase Deficiency · Ornithine Transcarbamylase Deficiency Disease · Ornithine Carbamoyltransferase Deficiency (Disorder)  ·  Sponsor: iECURE, Inc.

PhasePhase 1/Phase 2
Planned participants20
Who can joinMale, 24 Hours to 7 Months
Healthy volunteersNo

About this study

Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia. Individuals with OTC deficiency can develop elevated levels of ammonia in the blood, potentially resulting in severe consequences, including cumulative and irreversible neurological damage, coma, and death. The most severe form presents shortly after birth and occurs more commonly in boys than girls. This is a Phase 1/2/3, open-label, multicenter study evaluating the safety, efficacy, and dose of ECUR-506 in male babies with neonatal-onset OTC deficiency. The primary objective is to evaluate the safety, tolerability, and efficacy of up to three dose levels of ECUR-506 following intravenous (IV) administration of a single dose.

This description comes directly from the study's public registry record.

Talk to the study team

George Diaz, M.D., Ph.D.  ·  1-877-694-3558  ·  medinfo@iecure.com

Trial Recruitment  ·  clinicaltrials@iecure.com

Always discuss trial participation with your own doctor first.

Locations (12)

UCLA Mattel Children's HospitalLos Angeles, California, United StatesRecruiting
Children's Hospital of Colorado, Anshutz Medical CampusAurora, Colorado, United StatesRecruiting
Emory University School of MedicineAtlanta, Georgia, United StatesRecruiting
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois, United StatesRecruiting
Icahn School of Medicine at Mount SinaiNew York, New York, United StatesRecruiting
Oregon Health and Science UniversityPortland, Oregon, United StatesRecruiting
The Children's Hospital at WestmeadSydney, New South Wales, AustraliaActive Not Recruiting
The Royal Children's HospitalMelbourne, Victoria, AustraliaActive Not Recruiting
Hopsital Sant Joan de DeuBarcelona, SpainRecruiting
Hospital Universitario 12 de OctubreMadrid, SpainRecruiting
Great Ormond Street HospitalLondon, United KingdomRecruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust- Great North Children's HospitalNewcastle upon Tyne, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06255782