A phase I, single center, randomized, double-blind, placebo controlled, single dose (SD) and multiple dose (MD), dose-escalation clinical trial to evaluate the tolerability and preliminary antiviral activity of therapeutic hepatitis B adenovirus injection (T101) in chronic hepatitis B patients

INTERVENTION: Single Dose (SD) Cohort:3 different dosage groups are set up, 4 patients in each group will be randomized to receive T101 or placebo, 3 patients will be subcutaneously injected with T101, 1 patient will receive placebo.1 time at day 1, the doses were 1.0E+9, 1.0 E+10, 1.0 E+11 VP or placebo.;Multiple Dose (MD) Cohort:2 different dosage groups are set up,12 patients in each group will be randomized to receive T101 or placebo, 9 patients will be subcutaneously injected with T101, 3 patients will receive placebo.3 times at day 1, day 8 and day15,the doses are 1.0 E+10 and 1.0 E+11 VP or placebo.; CONDITION: chronic hepatitis B virus (HBV) infection PRIMARY OUTCOME: Tolerance evaluation including AE,symptom, Clinical laboratory tests,vital sign,ECG,physical exam; SECONDARY OUTCOME: HBsAg quantitative levels; HBeAg quantitative levels;Immune responses factors; INCLUSION CRITERIA: 1) Signed, written Independent Ethics Committee (IEC)‐approved informed consent; 2) Patients can cooperate to finish the trial in accordance with the requirements of protocol; 3) Patients (including partners) are willing to have no pregnancy program and take effective contraceptive measures voluntarily from the initiation of trial to 6 months after the last administration; 4) aged 18 to 65 years; 5) Body weight is no less than 50 kg for male or no less than 45 kg for female and body mass index(BMI) must be within the range of 18‐30kg/m2; 6) Compensated liver disease; defined as total bilirubin =2 × ULN, PT = 1.2 ×ULN, platelets =100,000/mm3(100*10^9/L), serum albumin =35 g/L, and no prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage); 7) Patients must be receiving antiviral treatment with nucleoside analog and have negtive HBV DNA(defined HBV DNA <20 IU/Ml); 8) Chronic hepatitis B