| Eligibility |
Inclusion Criteria:
Subjects must meet all inclusion criteria at screening (or as noted) to be eligible for
study participation, as follows:
1. Informed consent signed and dated by the subject
2. Healthy male and female subjects of any ethnic and racial origin, aged 20 to 45 years,
inclusive
3. Female subjects who:
- Are postmenopausal (defined as a minimum of 12 consecutive months of spontaneous
amenorrhea confirmed by a serum follicle-stimulating hormone level > 40 IU/L), or
- Are surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal
ligation), confirmed by medical documentations, or
- Are of child-bearing potential must agree to use at least 1 highly effective
method of contraception from at least 1 month prior to the initiation of the
study through 3 months after the final dose, where highly effective methods of
contraception include:
- Intrauterine device
- Intrauterine system
- Contraceptive implant
- Combined injectable contraceptives
- Hormonal oral contraceptives when used in combination with male condoms with
spermicide
- If a female subject confirms that her male partner(s) has been verified to be
clinically sterile (ie, documented infertility or surgical sterilization), this
method is acceptable as the only means of contraception
Note: The following are not acceptable methods of contraception:
- Periodic sexual abstinence (eg, calendar, ovulation, symptothermal, and
post-ovulation methods), declaration of sexual abstinence for the duration of the
study, withdrawal, and lactational amenorrhea method
- Spermicides alone
- Hormonal oral contraceptives alone
- Male condoms used in combination with female condoms or
- Agrees to practice true abstinence, when this is in line with the preferred and
usual lifestyle of the subject.
4. Male subjects who are sexually active and whose partners are females of child-bearing
potential, even if surgically sterilized (ie, status post vasectomy), who:
- Avoid sperm donation during the entire study period and through 90 days after the
last dose of study drugs, and
- Agree to practice effective barrier contraception, or
- Agree to practice true abstinence, when this is in line with the preferred and
usual lifestyle of the subject
5. Body mass index (BMI) of 19 to 30 kg/m2 (inclusive) (BMI = weight (kg)/(height [m])2)
6. Non-smokers (defined as having abstained from tobacco- or nicotine-containing products
[eg, cigarettes, chewing tobacco, snuff, nicotine patches, and electronic cigarettes]
in the 6 months prior to screening), stable light smokers, and ex-smokers will be
included. Stable light and ex-smokers are defined as follows: "A light smoker is
defined as someone smoking =5 cigarettes per day; an ex-smoker is someone who has
completely stopped smoking for at least 3 months."
7. In good health, as determined by the investigator at screening and confirmed at
check-in, with no clinically significant findings from medical history, physical
examination, 12-lead ECG, vital signs measurements, and clinical laboratory
evaluations
8. Subjects must be willing to understand and able to comply with all research procedures
and restrictions, and are able to communicate effectively with researchers.
Exclusion Criteria:
Subjects will not be eligible for study participation if they meet any of the exclusion
criteria at screening (or as noted), or will be discontinued at the discretion of the
investigator in consultation with the medical monitor if they develop any of the exclusion
criteria during the study.
1. History of any hypersensitivity or allergic reaction to active ingredients or
excipients of the study drugs (eg, known allergy to bisulfite containing foods such as
bottled lemon juice, grape juice, canned fruits, wine, jam, jelly, etc.)
2. Positive test result for infectious diseases at screening or baseline, including human
immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus
antibody, and syphilis antibody
3. Positive alcohol test at screening or baseline, or has a history of alcohol abuse
(alcohol consumption in excess of 1 standard drink per day for women and 2 standard
drinks per day for men; whereby 1 standard drink is equivalent to 12 oz beer [5%
alcohol], 5 ounces of wine [12% alcohol], and 1.5 ounces of 80 proof [40% alcohol])
4. Females who are pregnant, planning to become pregnant, or breastfeeding during the
study or within 3 months after the study; or have a positive pregnancy test result at
screening or check-in
5. Any abnormal physical examination, vital sign, ECG, or laboratory values at screening
or check-in that are considered clinically significant by the investigator
6. Special dietary requirements or restrictions and cannot follow a uniform diet
7. History of febrile illness or evidence of active infection within 14 days prior to the
first dose
8. Any subject with SARS-CoV-2 infection, based on a rapid test or positive polymerase
chain reaction for SARS-CoV-2, or subjects who received the SARS-CoV-2 vaccine within
1 month prior to the first dosing, or plans to have the vaccine within 1 month after
the last dose
9. Positive drug screen at screening or check-in, or has a history of drug abuse within
the past 5 years
10. Clinically significant interventional therapies (surgery, paracentesis, etc.) within 3
months prior to the study, or plan to have any surgeries during the study
11. Blood loss of non-physiological reasons = 400 mL (ie, trauma, blood collection, blood
donation) within 3 months prior to the first dose of study drugs, or plan to donate
blood during this study and within 1 month after the last dosing
12. Currently uses more than 5 tobacco products (refer to inclusion criterion 6) per day
13. Received an experimental agent (eg, vaccine, drug, biologic, device, blood product, or
medication) within 3 months prior to the first dose of study drugs, or plans to
receive another experimental agent during the duration of this study
14. Is unwilling to abstain from alcohol-containing products and
xanthine/caffeine-containing products, including any foods and beverages, within 48
hours prior to the first dose
15. Used any over-the-counter medications or prescription drugs (other than hormone
replacement therapy, oral contraceptives, or 650 mg acetaminophen/day), nutritional
supplements, or herbal medicines within 1 month from screening, unless, in the opinion
of the investigator and sponsor, the drug will not interfere with study assessments
16. Abnormal renal function estimated glomerular filtration rate calculated using the
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 90 mL/min/1.73
m2
17. Abnormal QT prolongation of QTcF = 450 msec for males or QTcF = 470 msec for females
(confirmed by repeated examination)
18. History of hypokalemia or family history of long QT syndrome
19. Any current or historical conditions that may interfere with the
absorption/distribution/metabolism/excretion of the study drugs, in the opinion of the
investigator (eg, dysphagia, gastrointestinal diseases)
20. Any clinically relevant acute or chronic medical conditions or diseases of the
cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic,
psychiatric, immune, or dermatologic systems that would pose a risk to subject's
safety or interfere with the study assessments, as determined by the investigator
21. Poor venous access (eg, history of difficult blood draws) for blood sample collection
or intravenous dosing
22. Any other conditions that would, in the opinion of the investigator, put the subjects
at increased risk for participation in this study
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