drugset / Trial / NCT07685210
GenSci144 Tablets Phase I Clinical Trial
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GenSci144 | Small molecule | 25 mg | Oral |
| Subject | GenSci144 | Small molecule | 75 mg | Oral |