Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects

Inclusion Criteria:

1. Signed informed consent prior to any study-related procedures.
2. Male or female subjects 18 to 50 years of age inclusive.
3. Subject's body mass index (BMI) is ≥ 18 kg/m2 and ≤ 30 kg/m2.
4. Female subjects of childbearing potential must not be pregnant or lactating with anegative serum human chorionic gonadotropin (HCG) pregnancy test result at Screening,and negative urine pregnancy test on Day -1 (including Day -1 of Period 2 for SADdosing participants i.e., fed cohort).
5. Female subjects of childbearing potential must use an adequate method of contraceptionfrom Screening until 30 days after last dose of study medication. Acceptable methodsof contraception are barrier methods (female condom, diaphragm, cervical cap,spermicide, or intrauterine device [IUD]), surgical sterility (self-reported: tuballigation, hysterectomy, and/or bilateral oophorectomy), oral hormonal contraceptives,hormonal IUD, and/or postmenopausal status (defined as at least 1 year without mensesas demonstrated by medical history or subject report).
6. Male subjects must use an adequate method of contraception from Screening until 30days after last dose of study medication. Acceptable methods of contraception arebarrier methods (condom), surgical sterility (self-reported), must also refrain fromdonating sperm while on study medication and until 30 days after last dose of studymedication.
7. Subject is in good health as determined by vital signs, medical history, physicalexam, ECG, and safety laboratory analyses at Screening and during the study.
8. Subject is negative for SARS-CoV-2 virus at admission Day -1 and Day 1 (during theSAD, Fed portion of the study, and MAD).
9. Subject does not have dysphagia and discomfort with swallowing tablets/capsules.

Exclusion Criteria:

1. Subject has used an investigational product or device within 30 days prior toenrollment or during the study.
2. Subject has used prescription or non-prescription drugs (including vitamins, minerals,and herbal/plant-derived preparations) within 2 weeks of enrollment (excludinghormonal IUD, oral hormonal contraceptives, hormone replacement therapy, andacetaminophen) unless deemed acceptable by the Investigator in consultation with theSponsor.
3. Subject has a positive drug and/or alcohol test at Screening and on Day -1 (including
4. Day -1 of Period 2 for SAD dosing participants, i.e., fed cohort).
5. Subject has a history of drug or alcohol abuse within 2 years before Screening.
6. Subject is unable to abstain from ingesting alcohol or smoking for 72 hours prior todosing and throughout the study.
7. Concurrent use of probenecid, penicillin or other ß-lactams, or other drugs whichundergo active tubular secretion in the kidneys.
8. The subject has a clinically significant history of endocrinologic, hematologic,hepatic, immunologic, metabolic, cardiovascular, urologic, pulmonary, neurologic,dermatologic, psychiatric, renal, and/or other major diseases or malignancy.
9. Allergy to sodium benzoate.
10. Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6months or a suicide attempt in the past 3 years.