HBV
Conditions
Interventions
Group 1:TQ-A3334 with entecavir dispersible tablets, tenofovir disoproxil fumarate tablets, and TQ-A3334 tablets with entecavir dispersible tablets or tenofovir disoproxil fumarate
Group 2:TQ-A3334 with entecavir dispersible tablets, tenofovir disoproxil fumarate tablets, and TQ-A3334 tablets with entecavir dispersible tablets or tenofovir disoproxil fumarate
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions; 2) Ability to complete the study as required by the protocol; 3) Subjects (including partners) are willing to have no pregnancy plans for the next 6 months and voluntarily take effective contraceptive measures; 4) Male subjects aged 18-60 years (including 18 and 60 years old); 5) Male subjects weigh no less than 50 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 18 ~ 28kg / m2 (including the threshold); 6) Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1) More than 5 cigarettes per day for the first 3 months of the trial. 2) Allergies (multiple drugs and food allergies). 3) History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 ml of wine). 4) Donate blood or massive blood loss (> 450 mL) within the first three months of screening. 5) Have a history of dysphagia or any gastrointestinal disease affecting drug absorption. 6) Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers. 7) Take special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks before screening or have strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion and other factors. 8) Inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone. 9) There have been major changes in diet or exercise habits recently. 10) Take the research drug or participate in the drug clinical trial within three months before taking the study drug. 11) Any medication that alters liver enzyme activity was taken 28 days prior to screening. 12) Take any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days of screening. 13) Electrocardiographic abnormalities have clinical significance or male QTCb > 470ms. 14) Clinical laboratory tests have clinically significant abnormalities, or other clinical findings that show clinical significance within 6 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, blood, endocrine, tumor, lung) , immune, mental or cardiovascular and cerebrovascular diseases). 15) Viral hepatitis (including hepatitis B and hepatitis C), HIV antibody, and Treponema pallidum antibody screening positive. 16) Acute illness or concomitant medication from the screening stage to the study before administration. 17) Ingested chocolate, any caffeine-containing or jaundice-rich food or drink 24 hours before taking the study drug. 18) Have taken any alcoholic products or alcohol breath test positive within 24 hours prior to taking the study medication. 19) Those who are urinary sieve-positive or have a history of drug abuse or drug use in the past five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Cytokines (IFN-a, TNF-a, IL-6, IL-1RA, MCP-1, IP-10);ISG;Transcriptomics RNA;Lymphocyte ratio and function;Gene polymorphism analysis: IL28B Genotype rs12979860, rs8099917; TLR7 Genotype rs179008, rs3853839;Human whole genome sequencing; | — |
Countries
China
Contacts
Public ContactYanhua Ding
Outcome results
None listed