| Eligibility |
Inclusion Criteria:
- Eighteen to 45 years of age, inclusive, of either gender.
- A body weight of at least 50 kg (male participants) or 45 kg (female participants). A
Body Mass Index (BMI) of between 18 to 28 kg/m2, inclusive.
- Physical examinations, vital signs, and clinical laboratory tests are normal, or
non-clinically significant abnormal judged by Investigator.
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.
Exclusion Criteria:
- History or clinical manifestations of significant central nervous system,
cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal,
urological, endocrine or hematological disease that, in the opinion of the
investigator, would confound the study results or compromise subject safety.
- History or presence of alcohol or drug abuse, or illegal drug use.
- Loss or donation of blood (> 450 mL) within 3 months prior to the start of the
Screening Period.
- Any history of allergic drug reactions, or any contraindication to the use of
rifampin/rifamycin or a fluoroquinolone.
- Taking any medication known to induce or inhibit CYP enzymes within 28 days prior to
screening.
- Taking any prescribed or over-the-counter medications within 2 weeks prior to
screening, or during the trial, including vitamins, food supplements, herbal remedies,
or traditional Chinese remedies.
- Significant abnormal findings on clinical laboratory tests, in the opinion of the
Investigator, could jeopardize achieving the study objectives and/or compromise the
participant's safety, including but not limited to:
1. Hematology: hemoglobin (HGB), white blood cell (WBC), absolute neutrophil count
(ANC), or platelet count (PLT) < the lower limit of normal (LLN).
2. Liver function: aspartate aminotransferase (AST) > the upper limit of normal
(ULN), and/or alanine aminotransferase (ALT) > ULN, and/or total bilirubin > ULN.
3. Renal function: serum creatinine > ULN.
- Tests positive for the human immunodeficiency virus (HIV) antibody, treponema pallidum
antibody, hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody,
and/or urine drug screening.
- Abnormal findings on vital signs, in the opinion of the Investigator, could jeopardize
achieving the study objectives and/or compromise the participant's safety, including
but not limited to:
1. Body temperature (ear) = 37.5 ºC.
2. Blood pressure >140/90 mmHg, or <90/60 mmHg.
3. Pulse rate > 100 beat/min, or < 50 beat/min.
- Abnormal findings on CT scan of chest and abdominal ultrasonography, in the opinion of
the Investigator, could jeopardize achieving the study objectives and/or compromise
the participant's safety.
- Any ECG abnormality considered to be clinically significant by the Investigator, or
QTcF interval (QT interval corrected for heart rate per Fridericia's formula) > 450
msec.
- Abnormal findings on physical examination, in the opinion of the Investigator, could
jeopardize achieving the study objectives and/or compromise the participant's safety.
- Smoking, or consuming coffee, tea, cola, chocolate, grapefruit/grapefruit juice, or
alcohol within 48 hours prior to the first dose of the study drug.
- Use of = 5 cigarettes per day within 3 months prior to screening. Participants may not
smoking during the study.
- Consume = 14 units of alcohol (1 unit = 285 mL beer, or 25 mL hard liquor/spirits, or
100 mL wine) per week within 6 months prior to screening; or cannot stop consumption
of alcohol during the study.
- Received any investigational medication or participated any clinical study within 3
months prior to signing ICF.
- If female, the participant is pregnant, lactating, or serum pregnancy test positive
during the screening.
- Cannot abstinence or effective methods of birth control, including his/her partner,
during the study and within 12 weeks after the last dose of study drug.
- Venous access considered inadequate for PK sample collection; history or evidence of
adverse symptoms associated with phlebotomy or blood donation.
- Any other reason that, in the opinion of the Investigator, would render the subject
unsuitable for study enrollment.
|
