Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients

Exclusion Criteria

• •1\) Addicted to smoking (\>5 cigarettes per day) for 3 months prior to the initiation of trial.
• •2\) Subjects susceptible to allergies, including a history of allergy to investigational medical product (IMP) or its buffer.
• •3\) History of drug abuse and/or alcohol abuse(≥14 units of alcohol per week; 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine).
• •4\) Patients who have donated or lost an amount of blood\> 450ml within 3 months prior to the screening of the trial.
• •5\) Patients who are positive urine test of drug on screening or a history of drug abuse or use of narcotic drugs during the past five years.
• •6\) Patients who have used any drug that can alter the enzyme activity of liver within 28 days prior to screening.
• •7\) Patients who have taken any prescription, nonprescription, vitamin product or herbal medicine within 14 days prior to the screening(except for nucleoside analogues).
• •8\) Patients who have taken a special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks prior to screening, or have strenuous exercise, or other factors that affect drug absorption, distribution, metabolism and excretion.
• •9\) Patients who are taking inhibitors or inducers of CYP3A4, P-gp or Bcrp such as itraconazole, ketoconazole or dronedarone.
• •10\) Patients who have significant changes in diet or exercise habit.
• •11\) Patients who have participated in any clinical trial or taken any IMP within 3 months prior to the trial.
• •12\) Patients with an clinically significant and abnormal ECG.
• •13\) Female patients who are pregnant, breast-feeding or positive result of pregnancy test.
• •14\) Patients with abnormal laboratory test results that have clinically significant or clinically significant disease(including but not limited to the gastrointestinal tract, kidney, liver, neurological, haematological, endocrine, lung, immune, mental or cardiovascular disease).
• •15\) Patients with α-fetoprotein \> 50 ng/Ml.
• •16\) Patients with positive hepatitis C antibody, HIV antibody, or Treponema pallidum antibody on screening.
• •17\) Patients who could not be enrolled in the judgement of the investigators.
• •18\) Patients with acute disease or accompanied medication on screening.
• •19\) Patients who have taken chocolate or any food and drink that are rich in caffeine or xanthine within 48 hours prior to the administration of IMP.
• •20\) Patients who have taken any alcohol product within 24 hours prior to the administration of IMP.