chronic hepatitis B
Conditions
Interventions
Health Group:None
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for healthy adult participants in Phase Ia include: (1) Age between 18 and 55 years; (2) Body mass index (BMI) between 18 and 28 kg/m^2, with a minimum weight of 50 kg for males and 45 kg for females; (3) Ability to communicate normally with medical staff and voluntarily sign the informed consent form. 2. Inclusion criteria for patients with chronic hepatitis B in Phase Ib include: (1) Age between 18 and 65 years; (2) Body mass index (BMI) between 18 and 32 kg/m^2; (3) HBsAg positive for at least 6 months, HBeAg negative, and receiving at least 6 months of stable monotherapy with a nucleotide analog including tenofovir, tenofovir alafenamide, or entecavir; (4) At screening, serum ALT <= 2 times the upper limit of normal, HBV DNA below 100 IU/mL; during the dose escalation phase, HBsAg between 100 and 1000 IU/mL; during the dose expansion phase, HBsAg between 1000 and 3000 IU/mL.
Exclusion criteria
Exclusion criteria: Directly adopt the exclusion criteria from Phase I clinical trials 1. Exclusion of healthy participants in Phase Ia (1) History of clinically significant diseases including gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, (2) Allergic constitution, (3) Prolonged QTc interval, (4) Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis treponemal antibody, (5) History of drug abuse, long-term alcohol consumption, or smoking habits. 2. Exclusion of patients in Phase Ib (1) Combined with other liver diseases including hepatitis caused by other pathogens, hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, severe non-alcoholic fatty liver disease, drug-induced liver injury, etc.; liver cirrhosis or decompensated liver function, history of malignant tumors, history of vasculitis, having received any oligonucleotide or small interfering RNA therapy within 12 months prior to screening, etc. (2) At the same time, participants cannot participate in other clinical trials or clinical studies during the study period except for the SG12 clinical trial program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genomic indicators, Mainly focus on single nucleotide polymorphism sites related to drug metabolism, immune response, and liver and kidney function;Transcriptomics indicators, including changes in gene expression profiles at different time points before and after drug administration;Proteomics indicators, including differentially expressed proteins in plasma; | — |
Countries
China
Contacts
Public ContactJianxiong Zhang
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed