HA35 Acute Alcohol Study

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT05025865
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy Controls

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Sodium Hyaluronate — DRUG
    Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.
  • Placebo — DRUG
    A placebo will be given in capsule form to study participants.

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
Nov 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: HA35 Placebo Group
    12 study participants will be given a placebo capsule to take once per day in the morning with breakfast for 3 days.
  • Active Comparator: HA35 Treatment Group
    12 study participants will be given an HA35 capsule to take once per day in the morning with breakfast for 3 days.

Primary Outcome Measure

Change in Aspartate Aminotransferase (AST) [ Time Frame: Baseline to day 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Annette Bellar
[email protected]

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By research site
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