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Not Yet Recruiting
NCT05623501
Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat Alcohol-Associated Liver Disease
Conditions: Alcohol-Related Disorders
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 12
Sponsor: University of Southern California
Location: United States
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).
Eligibility Criteria
Inclusion Criteria:No prior medical history of alcohol use disorder or alcohol-associated liver diseaseBetween 18-60 years oldExclusion Criteria:Weight below 50kg.Advanced liver diseaseOther acute liver diseasesHIV co-infectionHistory of pancreatic or biliary diseaseAcute illness that would interfere with drug absorptionPregnancyParticipants who are currently taking drugs with CYP3A4 effects
Source: ClinicalTrials.gov (NCT05623501). StuddyBuddy aggregates publicly available trial information.
