a clinical trial to evaluate the efficacy and safety of tqa3605 tablets in treatment-naive chronic hbv-infected subjects

Conditions: Chronic Hepatitis B

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase ii study, in which all participants are required to use tqa3605 tablets/placebo in combination with entecavir. the purpose is to evaluate the efficacy and safety of tqa3605 tablets combined with entecavir in treatment-naive chronic hbv-infected subjects. a total of 215 subjects are required.


Eligibility criteria:
inclusion criteria: * 18-65 years old (including boundary values), regardless of gender; * screening requires virological , clinical or pathological evidence of hepatitis b virus infection for more than 6 months; hbsag positive, hbeag positive, alt≤5×uln at screening; * never received nucleoside (acid) analog or interferon treatment, or previously received no more than 12 weeks of treatment but had discontinued therapy at least 6 months prior to the screening visit; * ability to communicate effectively with researchers and understand and comply with the requirements of this study, understand and sign the informed consent form; * male subjects with female partners who have fertility or female subjects of childbearing age are willing to voluntarily adopt effective contraceptive measures screening to within 3 months after leaving the group. exclusion criteria: * pregnant (positive pregnancy test) or lactating women. * co-infection with other viruses such as hepatitis a virus (hav), hepatitis c virus (hcv), hepatitis d virus (hdv), hepatitis e virus (hev), human immunodeficiency virus (hiv), syphilis, etc.; * history of cirrhosis or evidence of significant fibrosis or cirrhosis before or during screening; * history of hepatocellular carcinoma (hcc) or suspected hcc before or during screening.; * history of malignant tumors within the past 5 years prior to screening, except for certain cancers that can be completely cured by surgical resection; * subjects with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, wilson's disease, gilbert syndrome, etc; * previous organ or bone marrow transplantation; * clinically significant abnormal laboratory test results at screening. * poorly controlled thyroid diseases or clinically significant thyroid dysfunction; * autoimmune diseases; * significant systemic or major illnesses other than liver disease. * any systemic anti-tumor or immunosuppressive therapy, or immunomodulatory therapy within 6 months prior to screening. * high-dose systemic corticosteroids use within 3 months prior to screening; * history of alcohol or drug abuse within the past year or excessive alcohol consumption. * history of blood transfusion within 2 months prior to screening; * history of allergy to investigational drug or its excipients. * previously participated in the clinical trial of hepatitis b core protein allosteric modulators; * participation in another clinical trial and receipt of an investigational drug within the following timeframes before the first dose in this study: 5 half-lives (if known) or twice the duration of the biological effect of the study treatment (if known), whichever is longer, or 90 days (if the half-life or duration is unknown); * history or condition of cardiovascular disease; * any other condition deemed inappropriate for inclusion by the investigator.