Clinical Trial

Safety and Efficacy Study of NGGT002 in PKU Adult Subjects

Active, Not Recruiting Early Phase 1
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Summary
This is a single-center, open-label, non-randomized, dose escalation study to evaluate the safety, tolerability and efficacy of NGGT002 in adult Phenylketonuria (PKU) subjects. All subjects will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years.
Protocol Amendment History 1 change
critical Enrollment closed, study ongoing 2026-08-07
Trial Details
NCT Number NCT06061614
Lead Sponsor The First Affiliated Hospital of Bengbu Medical University
Conditions Phenylketonurias
Enrollment 15 participants
Start Date 2023-03-30
Primary Completion 2028-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06