chronic hepatitis B
Conditions
Interventions
Part 1a:VD1219 or control
Part 1b:VD1219
Part 1c:VD1219 or control
Part 1d:VD1219 & Entecavir
Part 2:VD1219
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Part 1 Healthy subjects: 1. Chinese healthy males and females, aged 18-45 (including threshold). 2. The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg. 3. The subjects are willing to voluntarily take effective contraceptive measures within 3 months after the last study drug administration. 4. Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment; 5. Willing and capable of complying with the requirements of the test plan. Part 2 Chronic Hepatitis B Patients: 1. Male and female subjects aged 18-65 years (including threshold); 2. BMI between 18-32 kg/m2 (including critical value); 3. Previous liver biopsy results show chronic hepatitis B, or there is evidence (including but not limited to previous medical records or test sheets, etc.) proving that hepatitis B virus surface antigen (HBsAg) or HBV DNA is positive for = 6 months at the time of screening; 4. Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment; 5. Able to complete the research according to the requirements of the experimental plan; 6. The subjects are willing to voluntarily take effective contraceptive measures within 3 months after the last study drug administration from screening; 7. Positive HBeAg during screening period, with serum HBV DNA = 2 × 104 IU/mL; The quantitative level of HBsAg is 2000-10000 IU/mL; 8. Screening period 1 × ULN = ALT = 8 × ULN, or ALT = 1 × Subjects with ULN and age greater than 30 years who have been evaluated by the researchers as eligible for enrollment.
Exclusion criteria
Exclusion criteria: Part 1 Healthy subjects: 1. Suffering from any disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers; 2. Individuals with difficulty swallowing or a history of gastrointestinal, liver, or kidney diseases that affect drug absorption or excretion within 6 months prior to screening (whether cured or not) or a history of surgery; 3. Allergic constitution; 4. Those who have received antiviral treatment with matrine, Shandou root (Ganyanling injection), or thymosin within the past 12 months; 5. Acute illness or concomitant medication occurring within 2 weeks prior to screening and before study medication; 6. Taking any prescription, over-the-counter, vitamin product, or herbal medicine within 14 days prior to the first medication use; 7. Screening for individuals with an average daily smoking volume of more than 5 cigarettes in the first 3 months; 8. Those who have a history of alcohol abuse or have used drugs within the past five years; 9. Within 7 days before taking the first medication, engage in high-intensity physical exercise or other factors that affect drug absorption, distribution, metabolism, and excretion; 10. Screening for individuals with significant changes in diet or exercise habits within the first three months; 11. Abnormal electrocardiogram or other clinically significant abnormalities determined by clinical doctors; 12. Those who are positive for urine drug screening; 13. Female subjects are currently breastfeeding or have positive serum pregnancy results during the screening period or trial process; 14. Clinical laboratory examination abnormalities have clinical significance; 15. Any one of hepatitis B virus surface antigen, hepatitis C virus antibody Anti HCV, treponema pallidum specific antibody, HIV antigen antibody is positive; 16. Donate blood or experience significant blood loss within 3 months prior to screening; 17. Have taken the research drug or participated in clinical trials within 90 days prior to screening; 18. Subjects who the researchers believe have other factors that are not suitable for participating in this experiment. Part 2 Chronic Hepatitis B Patients: 1. Patients with a history of alcoholic liver disease, moderate or above non-alcoholic fatty liver disease, autoimmune liver disease, Gilbert syndrome or other hereditary liver disease, drug-induced liver disease, and other chronic liver diseases; 2. Patients with advanced liver fibrosis or cirrhosis; 3. Patients with a history of hepatocellular carcinoma, or those with alpha-fetoprotein levels greater than 50 ng/mL during screening, or those with imaging findings suggesting a possibility of malignant liver mass; 4. Those who have or have a history of other malignant tumors. Subjects currently evaluating potential malignant tumors; 5. Those who have received organ transplantation or hematopoietic stem cell transplantation in the past; 6. Those who have had major injuries or undergone major surgeries within the past three months; 7. Those who have previously received interferon antiviral therapy and have received nucleoside (acid) analogues or other types of antiviral therapy within the first 6 months of the screening period; 8. It is necessary to take immune modulators for a long time, or drugs with high risk of nephrotoxicity or hepatotoxicity, or drugs that affect renal excretion; 9. Take traditional Chinese medicine with antiviral activity within 14 days before the first medication use; 10. Allergic c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital Signs; ECG;Blood;Urine;Blood biochemistry;Stool;coagulation;blood sugar;HBV RNA;HBsAg;HBeAg; | — |
Countries
China
Contacts
Public ContactRen Hong , Yu Xian
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed