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

ConditionAlcohol-Related Disorders

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-60

SponsorUniversity of Southern California

About this trial

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).

Eligibility criteria

Qualifiers

No prior medical history of alcohol use disorder or alcohol-associated liver disease

Between 18-60 years old

Disqualifiers

Weight below 50kg.

Advanced liver disease

Other acute liver diseases

HIV co-infection

Trial design

Treatments tested in this trial

Dihydromyricetin

Treatment groups

12 Participants

are divided into 4 treatment groups

Sponsors and collaborators

University of Southern California

Lead sponsor

Source ClinicalTrials.gov