Clinical Trial

To Evaluate the Safety and Efficacy of GS1168 Injection in Adult Phenylketonuria

Name: To Evaluate the Safety and Efficacy of GS1168 Injection in Adult Phenylketonuria — clinical trial record (NCT07318909)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Not Yet Recruiting Early Phase 1

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Summary

This study is a single-arm, open-label, dose-escalation, exploratory study to evaluate the safety, tolerability, and efficacy of a single administration of GS1168 Injection in Chinese adult phenylketonuria (PKU) with PAH mutation.

Trial Details

NCT Number	NCT07318909
Lead Sponsor	Gritgen Therapeutics Co., Ltd.
Conditions	Phenylketonuria (PKU)
Enrollment	9 participants
Start Date	2025-12-31
Primary Completion	2027-08-30 (estimated)
Study Completion	2031-08-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-06