HA35 Acute Alcohol Study

NCT05025865 | Recruiting Early Phase 1

• 1 other identifier: 21-486
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Controls

Outcome Measures

Primary Outcomes (2)

• Change in Aspartate Aminotransferase (AST)

  change in units/liter (U/L)

  Baseline to day 4

• Change in Alanine Aminotransferase (ALT)

  change in units/liter (U/L)

  Baseline to day 4

Study Arms (2)

HA35 Placebo Group

PLACEBO COMPARATOR

12 study participants will be given a placebo capsule to take once per day in the morning with breakfast for 3 days.

Drug: Placebo

HA35 Treatment Group

ACTIVE COMPARATOR

12 study participants will be given an HA35 capsule to take once per day in the morning with breakfast for 3 days.

Drug: Sodium Hyaluronate

Interventions

Sodium Hyaluronate DRUG

Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.

Also known as: HA35

HA35 Treatment Group

Placebo DRUG

A placebo will be given in capsule form to study participants.

HA35 Placebo Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Srinivasan Dasarathy, MD

CONTACT

216-318-7010; dasaras@ccf.org

Annette Bellar

CONTACT

bellara@ccf.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 27, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)