Assessing the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication

Inclusion Criteria:

• English-literate, non-smoking (> 6 months),

• Men and women aged 25 to 45 years,

• Body mass index (BMI) of 18.5 to 32.0 kg/m2, and weighing between 110 and 220 lbs (50-100 kg).

• Free of the diseases listed in exclusion criteria according to their medicalhistory,

• An ECG value of ≤ 440 msec for males and ≤ 460 msec for females, as measured by anFDA-cleared ECG device (6-lead device, KardiaMobile), administered by theinvestigator.

• Capable of consuming 4-6 standard drinks for women or 5-7 standard drinks for men ona single occasion without experiencing moderate sedation, vomiting, or aggression,to be eligible for the study. Moderate sedation is defined as the subject must beable to communicate and follow simple directions following the consumption ofindicated number of drinks.

• Agree not to get tattoos or body piercings, or receive vaccines during the studyperiod, or 7 days prior to the study period.

• Female subjects who must test negative on a urine pregnancy test, and cannot bepregnant or lactating. All subjects are required to either refrain from sex or useat least one form of contraception throughout the study, including a condom oreither an oral or intrauterine contraceptive.

• Men who must agree not to donate sperm for 90 days following the trial.

• Experienced at least 2 hangovers

• Clinical laboratory values within the most recent acceptable laboratory test range,and/or values are deemed by the Investigator /Sub-Investigator as "Not ClinicallySignificant" as per CBC/CMP, urinalysis, and coagulation testing.

Exclusion Criteria:

• A known history or presence of any clinically relevant conditions affecting theliver, kidneys, gastrointestinal system, cardiovascular system, cerebrovascularsystem, lungs, endocrine system, immune system, musculoskeletal system, nervoussystem, psychiatric state, respiratory system, skin, or blood, unless deemed notclinically significant by the Investigator/Sub-Investigator. This includes asignificant history or current issues with gastrointestinal pathology, such aschronic diarrhea or inflammatory bowel diseases, or conditions affecting drugabsorption, distribution, metabolism, or excretion

• Major surgery within the past 6 months, a history of seizures, significant headtrauma, or neurosurgery, or any clinically significant illness within 30 days priorto dosing are also excluded

• Are on a ketogenic or very low carbohydrate diet within the past 30 days.

• Significant physical or organ abnormalities, a positive screening for a HIV,Hepatitis B or C (as determined by medical health questionnaires), or positive testresult for drugs with abuse potential (cannabis, amphetamines, barbiturates,cocaine, opiates, phencyclidine and benzodiazepines)

• Alcohol-naïve

• Positive pregnancy test

• A history of significant alcohol sensitivity

• A history of adverse reactions to power (energy) drinks or caffeine,

• Severe food allergies, or dietary restrictions.

• Allergic reactions to any ingredients in the FSD-F2R6-A-CP and placebo.

• A psychiatric history of certain disorders, a first-degree relative with specificpsychiatric or alcohol use disorders,

• An intolerance to blood sampling, recent blood or plasma donations within the past 60 days.

• Recently used enzyme-modifying drugs within the previous 30 days including stronginhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine,quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIVantivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine,glucocorticoids, phenytoin, St. John's Wort, and rifampicin).

• Current or past history within the last 2 years of alcohol or drug dependence (excluding caffeine and nicotine).

• Current or past history within the last 5 years of major depressive disorder,obsessive-compulsive disorder, panic disorder, anorexia nervosa, or bulimia nervosa.First-degree relative with current or historical Alcohol Use Disorder (AUD).

• Intolerance to and/or difficulty with blood sampling through venipuncture orindwelling catheter.

• Used of prescription medication (other than contraception or occasional paracetamol)or over-the-counter medications including supplements within 14 days prior tosession 1,

• A positive alcohol test at check-in on treatment day,

• Recent tattoos or piercings (within 7 days of study enrollment)

• Any condition deemed by the Investigator or Sponsor to interfere with studyparticipation will be excluded.