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).
No prior medical history of alcohol use disorder or alcohol-associated liver disease
Between 18-60 years old
Weight below 50kg.
Advanced liver disease
Other acute liver diseases
HIV co-infection
Parallel
Dihydromyricetin
DrugDose-escalation and lysine preparation
Pharmacokinetic of DHM
serum DHM metabolites will be performed using MRM mass
Adverse Events
The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 will be used to assess and grade AE severity
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