drugset / Trial / NCT05025865

HA35 Acute Alcohol Study

NCT05025865

Phase 0 Recruiting 24 enrolled The Cleveland Clinic
RandomizedParallel-groupTriple-blindBasic science

Summary

Eligible subjects will be asked to take a placebo/treatment capsule for a total of 3 days and then participate in a study visit on the fourth day. This study visit will include a medical exam, clinical labs, questionnaires, body composition measurements, and urine and stool collections. Additionally, participants will consume a sugar cocktail to measure their gut permeability, participate in an acute ethanol challenge, and undergo two muscle biopsies. The study will take approximately 3-4 hours and a designated driver will need to drive the participant home. On the fifth day, you will be asked to return to drop of the 24-hour urine collection.

Timeline

Start
2022-02-01
Primary completion
2026-10-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Hyaluronate Other / unclassified

Indications

No indication recorded.