| Eligibility |
Inclusion Criteria:
1. Subject voluntarily has agreed to participate in this study and signed an
Institutional Review Board (IRB)-approved informed consent before any of the screening
procedures will be performed.
2. 18 to 65 years of age, inclusive, at screening, male or female.
3. Body mass index (BMI) between 17.5 and 32.0 kg/m2 at screening.
4. Healthy, determined by pre-study medical evaluation and Investigator/designee
discretion (medical history, physical examination, vital signs, ECG, and clinical
laboratory evaluations).
5. All female subjects of child-bearing potential must have a negative serum pregnancy
test result. All female subjects of child-bearing potential and male subjects and
their spouse/partner must agree to use a medically acceptable method of contraception
(e.g, abstinence, an intrauterine device, a double barrier method such as condom +
spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral
contraceptive or have a vasectomized partner with confirmed azoospermia) throughout
the entire study period, and for 90 days after study drug discontinuation.
6. Agrees to the collection of nasopharyngeal (NP) swabs for SARS-CoV-2 testing.
Exclusion Criteria:
1. Clinically significant history or evidence of cardiovascular, respiratory, hepatic,
renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric
disorder(s) as determined by the Investigator/designee.
2. Any disorder that would interfere with the absorption, distribution, metabolism, or
excretion of drugs.
3. Any concurrent disease or condition that, in the opinion of the Investigator/designee,
would make the subject unsuitable for participation in the clinical study.
4. Subject has history of alcohol and/or illicit drug abuse within one year of the
Screening visit.
5. Positive SARS-CoV-2 testing by standard RT-PCR assay.
6. Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody,
or human immunodeficiency virus (HIV) antibody.
7. Positive urine test for ethanol/drug/cotinine at Screening or Day -1.
8. History of alcohol abuse as judged by the Investigator within approximately 1 year.
Average weekly alcohol intake > 21 units/week or are unwilling to avoid use of alcohol
or alcohol-containing foods, medications or beverages, within 48 hours prior to Day -1
until completion of the study. Positive alcohol test at Screening. (One unit of
alcohol equals about 250 mL of beer or lager, 100 mL of wine, or 35 mL of spirits).
9. History of illicit drug abuse, within approximately 1 year or evidence of current use
as judged by the Investigator or are unwilling to abstain from illicit drug use
consumption during the entire study. Positive drug test, including marijuana.
10. Excessive consumption of coffee, tea, cola, or other caffeinated beverages; excessive
consumption is defined as >6 servings per day (1 serving contains approximately 120 mg
caffeine).
11. Donation of blood (> 500 mL) or blood products within 2 months prior to Day -1.
12. Use of over-the-counter (OTC) vitamins and medications, prescription medications, an
investigational drug or herbal remedies from 14 days prior to the first dose.
13. Subject has a history of hypersensitivity to the investigational product (IP) or any
of the ingredient or excipient of IP.
14. Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to
admission.
15. Subject has consumed grapefruit or grapefruit juice within the 14 days prior to
admission.
16. Pregnant or breast-feeding female subjects
17. Previous history of difficulty swallowing capsules.
18. History and/or family history of congenital long QT syndrome, unexplained syncope, or
other additional risks of Torsade de Pointes or sudden premature death.
19. Subject with any of the following ECG results at Screening or Admission will be
excluded:
1. PR interval >220 msec or <110 msec
2. RR interval > 1333 msec
3. QRS interval >120 msec
4. QTcF >470 msec
5. ST segment elevation or depression considered clinically significant by the PI or
designee
6. T-wave abnormalities considered to be clinically significant by the PI or
designee
20. An average systolic blood pressure =140 mmHg or = 90 mmHg; an average diastolic blood
pressure = 90 mmHg or = 50 mmHg.
21. Participants with history of hyperthyroidism and increased intraocular pressure.
22. Glomerular filtration rate (GFR) =70 mL/min/1.73 m2, as estimated by the Chronic
Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.at Screening
23. Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as
alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma
glutamyltransferase (GGT), or alkaline phosphatase (ALP) >1.2 × upper limit of the
reference range (ULRR) at Screening or Admission
24. History of significant multiple and/or severe allergies (including latex allergy);
anaphylactic reaction; or significant prescription drug, non-prescription drug, or
food intolerance.
25. Any vaccination within 7 days of Screening or any vaccination with an mRNA or
adenovirus platform vaccine within 30 days of Screening
26. Hemoglobin (HbA1C) > 6.5
27. Any other factors that the Investigator considers not suitable for participating in
this trial.
28. Subject is unable to understand the protocol requirements, instructions and study
related restrictions, as well as the nature, scope, and possible consequences of the
clinical study.
29. Subject is unlikely to comply with the protocol requirements, instructions and study
related restrictions, such as uncooperative attitude, inability to return for
follow-up visits, and improbability of completing the clinical study.
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