DHM for Liver Disease

Phase 1

Waitlist Available

Led By Brian Lee, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a new drug in healthy volunteers to determine its maximum tolerated dose.

Who is the study for?

This trial is for healthy volunteers aged 18-60 with no history of alcohol use disorder or liver disease. Participants must weigh over 50kg and not have acute illnesses, pancreatic/biliary diseases, advanced liver conditions, HIV, other liver diseases, or be pregnant. They also shouldn't be on drugs affecting CYP3A4 enzymes.

What is being tested?

The study tests the safety and appropriate dosage levels of Dihydromyricetin (DHM), a compound being explored to treat Alcohol-Associated Liver Disease. It's an open-label trial where everyone gets DHM in increasing doses to find the highest dose that's safe without severe side effects.

What are the potential side effects?

Since this is a first-in-human study for DHM, specific side effects are unknown but will be closely monitored throughout the trial. The focus is on any adverse reactions as dosages increase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and -0.5 (pre-dose), 0 (1st dose), 0.5, 1, 2, 4, 6, 8 (2nd dose), 10, and 24 hours post-dose. for reporting.