HBV
Conditions
Interventions
50mg 100mg 200mg 300mg:W28F
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 31 Years
Inclusion criteria
Inclusion criteria: 1. Male subjects aged 18-45 years with a BMI of 19-34 kg/m2 were included in the study; 2. Subjects have normal values for clinical laboratory tests and a normal medical history and examination; 3. Subjects totally understand and are willing to obey the procedure and method of this clinical trial, and sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Subjects smoke more than 5 cigarettes every single day befor scrreening; 2. Abuse any drug or alchol within 6 months prior to enrollment; 3. Have serious cardiovascular, lung, liver, kidneys, blood, gastrointestinal, endocrine, immune, skin, neurological diseases and mental illness of the past medical history or present illness; 4. Five years before the screening history of malignant tumor of any organ system, whether treated or untreated, and whether there is evidence of local recurrence or metastasis; 5. Clinically significant ECG abnormalities history or family history of long QT syndrome; 6. Subjects were excluded if they had a history or presence of gastrointestinal or renal disease or other codition known to interfere with the PK profile of drugs; 7. Abnormal clinical significance of changes in the medical screening examination; 8. History of renal impairment or disorder; 9. Liver function tests suggest liver disease or liver damage, ALT> 1.5 ULT and / or AST> 1.5 ULT and / or total bilirubin> 1.5 ULT, and the retest was diagnosed; 10. Got serious illnessinfection or trauma within 2 weeks prior to enrollment; 11. Whole 400 mL or more blood donation within 56 days prior to enrollment; 12. Multiple and recurrent history of allergies or known to be allergic to the test drug / similar drugs; 13. Engaged in any other clinical trial within 28 days prior to enrollment; 14. Use of any nonprescription drug within 14 days prior to enrollment; 15. Males of childbearing potential are not willing to use adequate contraceptive methods throughout the study; 16. Infection with HIV, HBV, HCV or Syphilis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of adverse event; | — |
Countries
China
Contacts
Public ContactLiu Xiao
Outcome results
None listed