chronic hepatitis B virus infection
Conditions
Interventions
experimental group:HT-102(BM012)injection
placebo group:HT-102(BM012)placebo
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1a Inclusion criteria: 1. Age: 18~50 years old (including the boundary value), male or female; 2. The body mass index (BMI, BMI= weight (kg)/height 2 (m2)) should be between 18.0 and 28.0 kg/m2 (including boundary values), and: ? men‘s weight 50 kg; ? women’s weight 45 kg . 3. The subjects were healthy people, defined as those with normal or abnormal 12-lead electrocardiogram, blood routine, urine routine, blood biochemistry, and coagulation routine, and without significant history of cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nervous, psychiatric and other diseases. 4. The subject undertakes to be childfree during the study period and for 3 months after the study, plan to donate sperm or eggs, and voluntarily use effective non-drug contraceptive methods (non-drug contraceptive methods include complete abstinence, condoms, contraceptive rings, subject ligation or partner ligation, etc.); 5. Before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, and voluntarily participated in this clinical trial. I can communicate well with the researchers, comply with the requirements of the whole study, and have signed a written informed consent. 1b Inclusion criteria: 1. Patients aged 18-65 years with chronic hepatitis B virus infection (including boundary values), male or female; 2. Male subjects weighed = 50.0 kg and female subjects weighed = 45.0 kg, with body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (including boundary values), (BMI= weight (kg)/height 2 (m2)); 3. Chronic HBV infection with negative HBeAg; 4. At least one year of antiviral therapy prior to screening, and =3 months of stable therapy with nucleoside (acid) reverse transcriptase inhibitors prior to screening (nucleoside (acid) reverse transcriptase inhibitors restricted to one of the following three types: Entecavir, Tenofovir fumarate, propofotenofovir fumarate tablets), and HBV DNA 200 IU/mL; 6. The subject undertakes to refrain from having children, plan to donate sperm or eggs, and voluntarily take effective non-drug contraceptive measures (non-drug contraceptive measures include complete abstinence, condoms, contraceptive rings, partner ligation, etc.) during and for 3 months after the trial; 7. Before the trial, I had a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, and voluntarily participated in the clinical trial. I could communicate well with the researchers, complied with the requirements of the whole study, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1a Exclusion Criteria (Healthy subjects who meet 1 of the following exclusion criteria are excluded) : 1. (for consultation) patients with a history of active pathological bleeding (such as peptic ulcer, intracranial bleeding, etc.), or with bleeding tendency (such as coagulopathy, recurrent gingival bleeding, etc.), or with a history of nervous system (such as headache and epilepsy, etc.); 2. Patients with abnormal HIV test or/positive hepatitis B surface antigen, hepatitis C antibody and treponema pallidum antibody during the screening period; 3. (Consultation) Patients who suffered major injuries or underwent major surgery within 3 months prior to screening, or who did not recover from surgery, or who underwent surgery that may significantly affect the in vivo course or safety evaluation of the test drug, or who are expected to have surgery plans during the course of the trial; 4. (Consultation) Blood loss or blood donation = 200 mL within 3 months prior to the screening of the test, or plan to donate blood during the trial or within 1 month after the end of the trial; 5. (Consultation) The subject is judged by the investigator to have a medical condition that affects drug absorption, distribution, metabolism, and excretion or that may reduce compliance; 6. (consultation) persons who have been vaccinated within 4 weeks prior to screening; 7. (Consultation) Patients with a history of drug allergy, or a history of specific allergy (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergy to two or more drugs, food and pollen), or known allergy to the components or analogens of the drug; 8. Those who have used or are using any drugs, including vitamins and Chinese herbs, in the 2 weeks prior to the screening test; 9. (for consultation) the average daily smoking amount in the month before screening is not less than 5, or do not agree to ban smoking during the test period; Who consumed an average of at least 14 units of alcohol per week (1 unit = 45 mL liquor, 150 mL wine, 350-360 mL beer) in the month prior to screening, or did not agree to abstain from alcohol during the test period; 10. (Consultation) Patients who have smoked, consumed alcohol or caffeinated food and beverages within 2 days prior to check-in and have a positive breath test for alcohol (or > 0.0mg/100mL); 11. (Consultation) persons with a history of substance abuse or drug use or those who have tested positive for urine drugs; 12. Large scar or tattoo on abdomen, thigh and upper arm, which affects drug administration, should be excluded; 13. Abnormal blood pressure (systolic > 140 mmHg or 90 mmHg or 100 bpm or 450ms, or abnormal and considered clinically significant by the investigator; 15. The results of abdominal ultrasound judged by clinicians as abnormal and clinically significant; 16. The results of laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.) during the screening period are judged by clinicians as abnormal and clinically significant; 17. (Consultation) Patients who have used other investigational drugs or medical devices in the 3 months prior to the trial screening, or plan to participate in other clinical trials during the study period; 18. (Consultation) women who are pregnant or breastfeeding or who have tested positive for pregnancy; 19. (consultation) Patients who cannot tolerate subc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Primary endpoint: Safety assessment measures (including Phase Ia and Ib) : All subjects were observed for any adverse events that occurred during the clinical study, including abnormalities in clinical symptoms and vital signs, and abnormalities in laboratory tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The concentration of HT-102 (BM012) in serum changed over time; Pharmacokinetic parameters;Changes of HBV DNA, HBsAg, HBV RNA, HBcrAg, HBcAb quantification from baseline in different dose groups (Subjects with chronic Hepatitis B virus infection); | — |
Countries
China
Contacts
Public ContactLu lungen
Shanghai General Hospital
Outcome results
None listed