| Eligibility |
Inclusion Criteria:
- Subject must have negative test results for hepatitis B surface antigen (HBsAg),
hepatitis B core antibody (HBcAb), anti-hepatitis C virus antibodies (anti-HCV) and
anti-human immunodeficiency virus (HIV) antibodies at Screening Visit
- Body weight = 50.0 kg for males, or = 45.0 kg for females, and body mass index within
the range of 18.0-28.0 kg/m2 (inclusive).
- A male subject must agree to use together with his female partner/ spouse a highly
effective contraception form of birth control in combination with a barrier method
throughout the clinical study period and until 90 days after the last dose of IMP.
Male subjects must also refrain from donating sperm from the time of informed consent
until 90 days after the last dose of IMP.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding,
and at least one of the following conditions applies:
- Non-childbearing potential (OR)
- A woman of childbearing potential (WOCBP) who agrees to use highly effective
methods of birth control in combination with a barrier method at least 3 months
prior to the Screening Visit until 30 days after the last dose of IMP.
- WOCBP must agree not to donate ova from the time of informed consent until 30
days after the last dose of IMP.
- WOCBP must have a negative serum pregnancy test at the Screening Visit.
Exclusion Criteria:
- History or presence of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.
- History/current symptom related to gastrointestinal abnormalities within 2 weeks
before the first dose.
- Subject is a pregnant or lactating women.
- Known or suspected hypersensitivity to the IMP or excipients of the IMP.
- Subjects with lactose intolerance/allergy.
- Known or ongoing psychiatric disorders, or active neuropsychiatric disease deemed
clinically significant in the opinion of the investigator.
- Subject has used over-the-counter or other oral medications (including vitamins),
prescription medications, or herbal remedies within 14 days before dosing.
- Subject has had major surgery within 3 months before Screening, or plan to perform
surgery during the study.
- Subject experiences an acute medical condition or uses concomitant medication during
the Screening period.
- Subject has been treated with an investigational drug within 30 days or 5 half-lives
(whichever is longer) preceding the first dose of the IMP.
- Subject has taken probiotic foods and/or drinks and/or health products within 1 week
before the first dose.
- History of alcohol and/or illicit drug abuse within 2 years before Screening.
- Subject has positive urine drug or alcohol test at the Screening Visit or Admission.
- No more than 5 cigarettes are allowed from screening to admission, and smoking is not
allowed from admission until after the last follow-up visit.
- Subject has donated or lost = 400 mL of whole blood within 3 months or donated plasma
within 14 days before Screening.
- Subjects has received vaccination within 14 days before the first dose or vaccination
planned during the study.
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