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

22-00428

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).

2024-01-01

2024-12-31

2024-12-31

Not yet recruiting

Early phase I

12

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single-center dose-escalation study. A total of 12 participants are planned and will be divided into 4 cohorts with 3 participants per cohort. Cohort 1 will consist of three healthy volunteers who will receive DHM in two doses of 300 mg. Cohort 2 will consist of three healthy volunteers who will receive DHM in two doses of 900 mg. Cohort 3 will consist of three healthy volunteers who will receive DHM in two 50mL PO solution doses of 300 mg plus 140mg L-lysine. Cohort 4 will consist of three healthy volunteers who will receive DHM in two 50mL PO solution doses of 900 mg plus 420mg L-lysine. Each participant will be administered the study drug during a 24-hour period. Evaluations will be taken at uniform intervals.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2023-11-22