chronic hepatitis B virus infection
Conditions
Interventions
experimental group:HT-101 injection
placebo group:HT-101 injection placebo
Sponsors
Beijing Friendship Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for healthy subjects: (1) Healthy subjects aged 18-50 (including boundary values); (2) No gender limit; (3) Male subjects with body weight >=50.0 kg and female subjects with body mass index (BMI) ranging from 19.0 to 28.0 kg/m^2 (including boundary values), (BMI= weight (kg)/height^2 (m^2)); (4) The subjects promise that they have taken effective contraceptive measures at least 1 month before screening, that they have no plans to give birth, sperm or egg donation during the trial period and 3 months after the trial, and that they voluntarily take effective physical contraceptive measures (including partners); (5) Had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial before the trial, voluntarily participated in the clinical trial, was able to communicate well with the investigators, complied with the requirements of the entire study, and signed a written informed consent. 2. Inclusion criteria for patients: (1) Aged 18-65 years with chronic hepatitis B virus infection (including the boundary value); (2) No gender limit; (3) Male subjects with body weight >=50.0 kg and female subjects with body mass index (BMI) ranging from 19.0 to 28.0 kg/m^2 (including boundary values), (BMI= weight (kg)/height^2 (m^2)); (4) Chronic HBV infection and stable treatment with nucleoside (acid) reverse transcriptase inhibitors for >=6 months (chronic HBV infection: clinical evidence of HBV infection >=6 months; Nucleoside (acid) reverse transcriptase inhibitors were restricted to the following three types: entecavir, tenofovir fumarate, propofol tenofovir fumarate tablets); (5) HBsAg quantitative level >200 IU/mL and <5000 IU/Ml; HBV DNA quantitative level <2×10^4IU/mL; (6) Subjects promise to have taken effective contraceptive measures at least 1 month before screening, have no plans to have children, sperm or egg donation during the trial period and 3 months after the trial, and voluntarily take effective physical contraceptive measures (including partners); (7) Had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial before the trial, voluntarily participated in the clinical trial, was able to communicate well with the researchers, complied with the requirements of the entire study, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for healthy subjects: (1) Have a history of drug allergy, or a history of specific allergy (asthma, urticaria, eczema, etc.), or have a constitution of allergy (such as allergy to two or more drugs, food and pollen) or known allergy to this drug component or similar; (2) Patients are found to have cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nervous, psychiatric and other system diseases after consultation or physical examination, or have clinically significant symptoms/signs, or the subjects self-report the above-mentioned diseases; (3) Patients with a history of active pathological bleeding (such as peptic ulcer, intracranial hemorrhage, etc.), or patients with bleeding tendency (such as coagulopathy, recurrent gingival bleeding, etc.); (4) Physical examination, vital signs examination, electrocardiogram examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, etc.) during the screening period were judged by clinicians as abnormal and clinically significant; (5) Those who were positive for HIV and/or positive for hepatitis B surface antigen, hepatitis C antibody and treponema pallidum antibody during the screening period; (6) Patients who suffered major trauma or underwent major surgery within 3 months prior to screening, or who did not recover from surgery, or who underwent surgery that could significantly affect the in vivo course or safety evaluation of the study drug, or who expected to have a surgical plan during the trial; (7) Patients who have used other clinical trial 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; (8) Had used or was using any drug, including vitamins and Chinese herbs, in the 2 weeks prior to screening; (9) Blood loss or donation >=200 ml within 3 months prior to screening, or plan to donate blood during the trial or within 1 month after the trial; (10) Those who had any acute stage of disease that the investigator determined to be clinically significant within 1 month before screening; (11) Those who had been vaccinated within 14 days prior to screening; (12) Smokers who smoked more than 5 cigarettes per day in the 30 days before screening, or did not agree to ban smoking during the test period; (13) Those who consumed >=14 units of alcohol (1 unit = 45mL liquor, 150 mL wine, 350-360 mL beer) per week in the 30 days before screening, or did not agree to abstain from alcohol during the trial; (14) Pregnant or lactating patients or pregnancy test positive; (15) Those who have a history of drug abuse or drug use, or those who test positive for urine drugs; (16) Smoke, drink or drink caffeinated food and beverages within 2 days prior to check-in, and test positive for alcohol breath test; (17) Those who cannot tolerate subcutaneous injection, or have a history of fainting needle and fainting blood, or are not suitable for venous blood collection; (18) The patient has a medical condition, as determined by the investigator, that affects drug absorption, distribution, metabolism, and excretion, or that reduces compliance; Patients may not be able to complete the study for other reasons, or may not be considered suitable to participate in the study by the investigator. 2. Exclusion criteria for patients: (1) Significant liver fibrosis or cirrhosis (progressive liver fibrosis or cirrhosis in the past s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-varying concentrations, pharmacokinetic parameters of HT-101 (and its metabolites, if necessary) in plasma and urine;The log value of hepatitis B virus surface antigen (HBsAg) reduction from baseline;Negative HBeAg conversion rate in Hepatitis B virus e antigen (HBeAg) positive patients;The log value of the decrease in HBV DNA level from baseline; | — |
Countries
China
Contacts
Public ContactJia Jidong
Beijing Friendship Hospital Affiliated to Capital Medical University
Outcome results
None listed