Recruiting
Early Phase 1

HA35

Sponsor:

The Cleveland Clinic

Code:

NCT05025865

Conditions

Healthy Controls

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Sodium Hyaluronate

Placebo

Study Details

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

Study ID

NCT05025865

Start date

Feb 1, 2022

Status verified date

Sep, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Sodium Hyaluronate

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

Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Srinivasan Dasarathy, MD

216-318-7010dasaras@ccf.org

Annette Bellar

bellara@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Annette Bellar

bellara@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.