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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT05623501
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Alcohol-Related Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Dihydromyricetin — DRUG
    Dose-escalation and lysine preparation

Study Details

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).

Key Dates

Start date
Sep 15, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    DHM 300mg x1 dose
  • Experimental: Cohort 2
    DHM 900mg x1 dose
  • Experimental: Cohort 3
    DHM 300mg x1 dose + Lysine 140mg x1 dose
  • Experimental: Cohort 4
    DHM 900mg x1 dose + Lysine 420mg x1 dose

Primary Outcome Measure

Pharmacokinetic of DHM [ Time Frame: -0.5 (pre-dose), 0 (1st dose), 0.5, 1, 2, 4, 6, 8 (2nd dose), 10, and 24 hours post-dose. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90089
Brian Lee, MD
[email protected]
866-797-2770
Matthew Dukewich, MD
[email protected]
866-797-2770
Matthew Dukewich, MD

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By research site
University of Southern California· Los Angeles, CA

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