Healthy ControlsEarly Phase 1NCT05025865
HA35 Acute Alcohol Study
A Early Phase 1 study testing Sodium Hyaluronate in people with Healthy Controls, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- Sodium Hyaluronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Oct 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Annette Bellar contact
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Annette Bellar, bellara@ccf.org
About this study
Official title: Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
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.
Read the detailed description
Interested subjects will be assessed for eligibility and a written informed consent will be obtained. The screening visit will consist of a medical exam, clinical labs (if not available in medical record), and questionnaires. Those who pass the screening will be eligible for a baseline visit (may be combined with screening if appropriate labs are already done). The baseline visit will include collection of blood, urine, and stool samples, body composition measurements, and randomization into either HA35 or placebo groups. Patients will be instructed to take the HA35 or placebo daily in the morning before breakfast 3 days prior to the day 4 visit. Patients will be informed that they will need to have a driver that is known to them for the day 4 visit. In the morning of the day 4 visit, confirmation of a driver will occur prior to starting study procedures. During the day 4 visit, patients will have an acute ethanol challenge where they will need to consume 2mL/kg of vodka in 100mL of juice in under 60 minutes. Muscle biopsies will be collected before and after the challenge and blood will be collected throughout the day. In addition, patients will be given lactulose/mannitol/sucralose/sucrose cocktail to measure gut permeability. The costs of any of these tests/procedures will not be billed to the patient and will be covered by the department. The participant will not be responsible for any costs.
- Conditions
- Healthy Controls
- Being tested
- Sodium Hyaluronate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateDrug
Also called HA35
Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.
PlaceboDrug
A placebo will be given in capsule form to study participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aspartate Aminotransferase (AST)
change in units/liter (U/L)
Measured: Baseline to day 4
Change in Alanine Aminotransferase (ALT)
change in units/liter (U/L)
Measured: Baseline to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Feb 2022
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025865
- Sponsor's protocol ID
- 21-486
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
- ClinicalTrials.gov ID
- NCT05025865
- Acronym / sponsor ID
- 21-486
- Conditions
- Healthy Controls
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interested subjects will be assessed for eligibility and a written informed consent will be obtained. The screening visit will consist of a medical exam, clinical labs (if not available in medical record), and questionnaires. Those who pass the screening will be eligible for a baseline visit (may be combined with screening if appropriate labs are already done). The baseline visit will include collection of blood, urine, and stool samples, body composition measurements, and randomization into either HA35 or placebo groups. Patients will be instructed to take the HA35 or placebo daily in the morning before breakfast 3 days prior to the day 4 visit. Patients will be informed that they will need to have a driver that is known to them for the day 4 visit. In the morning of the day 4 visit, confirmation of a driver will occur prior to starting study procedures. During the day 4 visit, patients will have an acute ethanol challenge where they will need to consume 2mL/kg of vodka in 100mL of juice in under 60 minutes. Muscle biopsies will be collected before and after the challenge and blood will be collected throughout the day. In addition, patients will be given lactulose/mannitol/sucralose/sucrose cocktail to measure gut permeability. The costs of any of these tests/procedures will not be billed to the patient and will be covered by the department. The participant will not be responsible for any costs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA35 Placebo Group | Placebo comparator | Drug: Placebo12 study participants will be given a placebo capsule to take once per day in the morning with breakfast for 3 days. |
| HA35 Treatment Group | Active comparator | Drug: Sodium Hyaluronate12 study participants will be given an HA35 capsule to take once per day in the morning with breakfast for 3 days. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium HyaluronateAlso: HA35Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants. | Drug | HA35 Treatment Group |
| PlaceboA placebo will be given in capsule form to study participants. | Drug | HA35 Placebo Group |
Primary outcome
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline to day 4
change in units/liter (U/L)
Change in Alanine Aminotransferase (ALT)
Time frame: Baseline to day 4
change in units/liter (U/L)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annette Bellar contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sodium Hyaluronate in people with Healthy Controls, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Srinivasan Dasarathy, MD (216-318-7010, dasaras@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aspartate Aminotransferase (AST) (time frame: Baseline to day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.