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Flavonoid

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), 12, and 24 hours post-dose.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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), 12, 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), 12, 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), 12, and 24 hours post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Pharmacokinetics

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention

DHM 900mg x1 dose + Lysine 420mg x1 dose

Group II: Cohort 3Experimental Treatment1 Intervention

DHM 300mg x1 dose + Lysine 140mg x1 dose

Group III: Cohort 2Experimental Treatment1 Intervention

DHM 900mg x1 dose

Group IV: Cohort 1Experimental Treatment1 Intervention

DHM 300mg x1 dose

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,306 Total Patients Enrolled

Brian Lee, MDPrincipal InvestigatorUniversity of Southern California

1 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Dihydromyricetin (Flavonoid) Clinical Trial Eligibility Overview. Trial Name: NCT05623501 — Phase 1

Alcohol Use Disorder Research Study Groups: Cohort 1, Cohort 2, Cohort 3, Cohort 4

Alcohol Use Disorder Clinical Trial 2023: Dihydromyricetin Highlights & Side Effects. Trial Name: NCT05623501 — Phase 1

Dihydromyricetin (Flavonoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623501 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent might members of Cohort 1 be exposed to risk?

"Due to the limited safety and efficacy data from its Phase 1 trial, Cohort 1 is estimated by our team at Power to have a low risk score of 1."

Answered by AI

Does this research include participants aged 60 and above?

"This trial is open to patients between 18 and 60 years old. There are separate studies for those that fall below the age of majority (27) as well as a distinct cohort for elderly individuals over 65 (237)."

Answered by AI

May I be accepted into this clinical research study?

"This study is accepting 12 individuals with a history of alcohol-induced issues aged between 18 and 60. Criteria for applicants include: no prior medical record of alcohol use disorder or liver disease related to drinking, plus meeting the aforementioned age group requirements."

Answered by AI

Is the research team currently accepting participants for this experiment?

"Evidence on clinicaltrials.gov indicates that this clinical trial is no longer looking for participants; the study was first published in December 1st 2022 and last edited November 11th 2022. While enrollment has been closed, there are 273 other trials actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Brian P. Lee 2024. "Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat Alcohol-Associated Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05623501.

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