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Safety and Efficacy Study of NGGT002 in Adult Patients With Phenylketonuria

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 30, 2026 → Aug 11, 2027
Primary endpoint reworded 1 of 2 changed
See other at-risk trials from NGGT (Suzhou) Biotechnology Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 30, 2026 to Aug 11, 2027v2 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Study completion moved earlier from Jul 30, 2031 to Jun 11, 2030
    • Start date: Jul 25, 2024 to Jul 16, 2024
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (4)
    • Study title expanded, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU). NGGT002 is a rAAV8 based vector carrying a functional copy of the human PAH gene. Participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years.
Trial Details
NCT Number NCT06687733
Lead Sponsor NGGT (Suzhou) Biotechnology Co., Ltd.
Conditions
(from sponsor)		 Phenylketonurias
Related terms Phenylketonurias
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov