University of Southern California
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).
Dihydromyricetin (DHM), a bioactive flavonoid from an edible plant (ampelopsis grossedentata), is reported to have multiple protective effects against chemical-induced liver injuries. For example, the antioxidant activity and cellular metabolic protective effects of DHM may act via the AMP kinase (AMPK) and nicotinamide adenine dinucleotide (NAD+)-dependent Sirtuin (Sirt)-1 energy regulating pathway. Furthermore, there is accumulating evidence supporting the use of DHM for the treatment of alcohol use disorder and the possible reduction/prevention of alcohol-associated liver disease in animal…
Inclusion Criteria: * No prior medical history of alcohol use disorder or alcohol-associated liver disease * Between 18-60 years old Exclusion Criteria: * Weight below 50kg. * Advanced liver disease * Other acute liver diseases * HIV co-infection * History of pancreatic or biliary disease * Acute illness that would interfere with drug absorption * Pregnancy * Participants who are currently taking drugs with CYP3A4 effects * FIB-4 Index \> 1.30 * History of Alcohol Use Disorder (AUD) determined by score \> 8 on AUDIT questionnaire
Dose-escalation and lysine preparation
Arctuva estimate
Verify or correct the compensation shown for this listing.