drugset / Trial / NCT07685210

GenSci144 Tablets Phase I Clinical Trial

NCT07685210 ↗

Phase 1 Recruiting 48 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindOther

Summary

This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels. It was conducted using a randomized, double-blind, placebo-controlled design, primarily to evaluate the drug's safety and tolerability, while also exploring its pharmacokinetic and pharmacodynamic characteristics in the body, providing a basis for subsequent clinical use in the treatment of phenylketonuria.

Timeline

Start
2026-06-22
Primary completion
2026-09
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject GenSci144 Small molecule 25 mg Oral
Subject GenSci144 Small molecule 75 mg Oral

Indications