| Eligibility |
Inclusion Criteria:
- Able to sign Inform Consent Forms before study, and fully understand the study
contents, process and potential adverse reactions;
- Able to complete the study in compliance with the protocol;
- Subjects (including their partners) agreed to adopt effective contraceptive
measurements from screening to 6 months after the last administration.
Part I Proprietary:
- Male and female subjects between 18 and 50 years of age, inclusive;
- At least 50 kg for male subjects, 45 kg for female, with a Body Mass Index (BMI)
between 18-28 ;
- Normal or abnormal but of no clinical significance results for physical examination
and vital signs.
Part II Proprietary::
- Male and female subjects between 18 and 65 years of age, inclusive;
- At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index
(BMI) between 18-35 kg/m2, inclusive, BMI = weight (kg) / height 2 (m2);
- Any proof of HBV infection more than 6 months (including outpatient/inpatient medical
records, HBV DNA, HBsAg test sheets, etc.); or with IgM HBcAb negative and HBsAg
positive at screening;
- No history of therapy including interferon/nucleoside or analog at screening, or
discontinuation for more than 1 year from interferon therapy or more than 6 months
from nucleoside analog therapy;
- HBV DNA = 2×105 IU/mL for HBeAg-positive patients and HBV DNA = 2×104 IU/mL for
HBeAg-negative patients at screening;
- Serum ALT lower than 5×upper limit of normal at screening.
Exclusion Criteria:
- Major trauma or surgery within 3 months before screening;
- History of treatment that may interfere with drug absorption (e.g, subtotal
gastrectomy);
- Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;
- Any history of allergy suspected to be due to any component of the study drug, or
allergic constitution (allergy to multiple drug and food);
- A history of narcotic drugs intake or alcohol abuse ;
- Acute infection within 2 weeks before screening;
- Suffering from serious diseases of the circulatory, respiratory, urinary, vascular,
endocrine, immune, mental and nervous systems;
- History of myocardial infarction, unstable angina, percutaneous coronary intervention,
coronary artery bypass grafting, heart failure of grade III or IV, or stroke within 6
months prior to screening;
- Patients with existing malignant tumors (except for skin non-melanoma, cervical
intraepithelial neoplasia, thyroid tumor, breast tumor, etc. after treatment with no
signs of recurrence);
- Any surgery or hospitalization anticipated during the study;
- Treatment history of immunosuppressants, immunomodulators (thymosin) and cytotoxic
drugs within 6 months before study administration;
- Medication history of definitely strong CYP3A4 inhibitors or inducers within 2 weeks
before screening;
- Involved in any other study drug administration or clinical study of medical devices
within 1 month before screening; Involved in any clinical study of HBV virus
nucleocapsid inhibitors in the past;
- Any abnormality of electrocardiogram not suitable for the study judged by physician;
- Positive pregnancy test results or subject is lactating for female subjects;
- Positive test results of HCV-Ab, HCV core antigen and HCV RNA (PCR); or HIV antibody;
or Treponema pallidum antibody further confirmed by rapid plasma reagin (RPR) test;
- Consumption of chocolate or any diets containing caffeine or rich in xanthine, or any
alcohol-containing products within 48 h before the initial administration;
- Positive results of drug abuse tests (morphine, marijuana) or alcohol breath tests;
- Other conditions in which subjects are not suitable for the study in the opinion of
investigators.
Part I Proprietary:
- More than 5 cigarettes everyday within 1 month before the study;
- Intake of any prescription or over-the-counter (OTC) drugs, vitamin, herbs, other
inappropriate diet or supplements in opinion of investigators within 7 days before
screening;
- Positive HBsAg test results;
- Any clinically significant abnormalities in laboratory tests.
Part II Proprietary :
- Estimated glomerular filtration rate (eGFR) ? 60 mL/min/1.73 m2 based on serum
creatinine and formula for modification of diet in renal disease (MDRD) based on
values at screening;
- Patients with clinically significant acute or chronic liver disease not caused by HBV
infection (including but not limited to alcoholic liver disease, severe or higher
non-alcoholic fatty liver disease, autoimmune liver disease, Gilbert syndrome or other
hereditary liver disease, drug-induced liver disease, etc. );
- Liver cirrhosis at clinical consideration or/and liver stiffness measurements (LSM) =
12.4 kPa (for patients with ALT greater than the upper limit of normal, LSM = 17.5
kPa); 27) Patients with clinically significant cardiac arrhythmias; history of risk
factors for Torsade de Pointes (TdP) syndrome;
- Uncontrolled hypertension with systolic blood pressure =160 mmHg or diastolic blood
pressure =100 mmHg at screening;
- Patients with type I diabetes, or with newly diagnosed or poorly controlled type II
diabetes (HbA1c > 8.5%);
- Left ventricular ejection fraction < 50%.
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