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 atScreening, and negative urine pregnancy test on Day -1 (including Day -1 of Period 2for SAD dosing participants i.e., fed cohort).

5. Female subjects of childbearing potential must use an adequate method ofcontraception from Screening until 30 days after last dose of study medication.Acceptable methods of contraception are barrier methods (female condom, diaphragm,cervical cap, spermicide, or intrauterine device [IUD]), surgical sterility (self-reported: tubal ligation, hysterectomy, and/or bilateral oophorectomy), oralhormonal contraceptives, hormonal IUD, and/or postmenopausal status (defined as atleast 1 year without menses as 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 (excluding hormonal IUD, oral hormonal contraceptives, hormone replacement therapy,and acetaminophen) unless deemed acceptable by the Investigator in consultation withthe Sponsor.

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).

4. Subject has a history of drug or alcohol abuse within 2 years before Screening.

5. Subject is unable to abstain from ingesting alcohol or smoking for 72 hours prior todosing and throughout the study.

6. Concurrent use of probenecid, penicillin or other ß-lactams, or other drugs whichundergo active tubular secretion in the kidneys.

7. 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.

8. Allergy to sodium benzoate.

9. Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years.