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New treatment option for Healthy Controls
Official title HA35 Acute Alcohol Study
ClinicalTrials.gov ID: NCT05025865
What this study is testing
What is Sodium Hyaluronate?
Sodium Hyaluronate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healthy controls.
Also referred to as HA35.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.