HA35 Acute Alcohol Study

This study is looking at how a capsule called Sodium Hyaluronate (HA35) might affect your liver after drinking alcohol. You could be eligible if you are a healthy adult between 21 and 65 years old, drink a moderate amount of alcohol, and don't have certain chronic illnesses. Participants will receive either Sodium Hyaluronate or a placebo (an inactive capsule). Researchers will measure changes in liver enzymes (Aspartate Aminotransferase or AST, and Alanine Aminotransferase or ALT) from the start of the study to day 4 to see if HA35 has an effect. The current status of this study is unclear, and it plans to enroll 24 healthy volunteers.

Study design
This is an interventional study that will enroll 24 healthy participants. You will be randomly assigned to receive either Sodium Hyaluronate or a placebo.
What's involved
You will take a capsule for 3 days, then have a 3-4 hour study visit on day 4 involving a medical exam, blood tests, questionnaires, body measurements, urine and stool collection, a sugar drink, an alcohol challenge, and two muscle biopsies. You will also need a designated driver for day 4 and will return on day 5 to drop off a 24-hour urine collection.
Compensation
Not stated in the trial record.
Follow-up
Your liver enzymes (AST and ALT) will be measured from baseline to day 4.

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NCT05025865

HA35 Acute Alcohol Study

Recruiting
EARLY_PHASE1Ages 21–65InterventionalBasic science
The Cleveland Clinic
~24 participants
Updated 2025-11-17 on ClinicalTrials.gov
What's tested:Sodium HyaluronatePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Aspartate Aminotransferase (AST)
Measured over Baseline to day 4
+1 more outcome measured
Healthy Controls
1 sites across 1 states
Ohio1

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Eligibility criteria

Inclusion

Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
Ability to understand and willingness to provide written consent

Exclusion

Any known chronic illness including but not limited to cancer (except non-melanoma skin cancer)
Poorly controlled diabetes (Hemoglobin A1c \>9.5 g/dl)
Untreated hyper/hypothyroidism
Uncontrolled hypertension or hypercholesterolemia
End-stage renal disease
Liver disease of any etiology
Coronary artery disease or stroke
Active intravenous drug use
History of gastric bypass
Medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)
Pregnancy
Past alcohol use disorder
Abnormal clotting factors
  • Change in Aspartate Aminotransferase (AST)Baseline to day 4

    change in units/liter (U/L)

  • Change in Alanine Aminotransferase (ALT)Baseline to day 4

    change in units/liter (U/L)