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

NCT07318909 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • Phenylketonuria (PKU)

Interventions

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 injection at dose level 2; 3. A single intravenous administration of GS1168 injection at dose level 3.

Sponsors & Collaborators

  • Gritgen Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-08-30
Completion
2031-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318909 on ClinicalTrials.gov