drugset / Trial / NCT05623501
Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat Alcohol-Associated Liver Disease
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The current proposal is designed as a first-in-human Phase 1 open-label, dose-escalation study to assess the safety, pharmacokinetics, and the maximum tolerated dose of DHM among healthy volunteers using a purified form of DHM from a local cGMP compliant source (Master Herbs, Inc).
Timeline
- Start
- 2024-09-15
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMPELOPSIN | Small molecule | 300 mg | Oral |
| Subject | AMPELOPSIN | Small molecule | 900 mg | Oral |