U.S., Jan. 7 -- ClinicalTrials.gov registry received information related to the study (NCT07318909) titled 'To Evaluate the Safety and Efficacy of GS1168 Injection in Adult Phenylketonuria' on Dec. 01, 2025.
Brief 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.
Study Start Date: Dec. 31, 2025
Study Type: INTERVENTIONAL
Condition:
Phenylketonuria (PKU)
Intervention:
DRUG: GS1168 injection
The dose levels are as follows:
1. A single intravenous administration of GS1168 injection at dose level 1;
2. A single intravenous administration of GS1168 ...