Not Yet RecruitingPhase 1

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

United States12 participantsStarted 2024-09-15

Plain-language 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).

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pharmacokinetic of DHM

Timeframe: -0.5 (pre-dose), 0 (1st dose), 0.5, 1, 2, 4, 6, 8 (2nd dose), 10, and 24 hours post-dose.

Adverse Events

Timeframe: 24 hours post-dose

Trial details

NCT IDNCT05623501

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Brian Lee, MD

323-442-5576 brian.lee@med.usc.edu

View on ClinicalTrials.gov More Alcohol-Related Disorders trials