Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat Alcohol-Associated Liver Disease

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Southern California

Criteria

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