Chronic Hepatitis B
Conditions
Brief summary
This study uses random, double -blindness, placebo control, and phase multi -center test design. All subjects who meet the standards receive TQ-A3334 per tablet/placebo nucleoside (acid) analog. A total of 116 subjects are needed.
Interventions
DRUGPlacebo
Placebo contains no active substance.
DRUGTQA3334 Tablet
Inhibit viral replication.
DRUGNucleoside (acid) analogs (NAs)
Inhibit viral replication.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Those who meet all the selected standards below can enter the group test: * The subject can communicate well with the researchers and understand and comply with the various items in this study, understand and sign the consent of informed consent; * 18-65 years old (including the boundary value), and men and women are not limited (calculated based on the date of signing the consent of informedness); * Serum virus standard: serum HBSAG positive for more than 6 months or more than 6 months chronic Evidence of HBV infection. * No obvious liver cirrhosis is judged by researchers; Those who have been treated after treatment need to meet the following conditions: * The subject must receive oral nucleoside (acid) drug treatment before screening ≥6 months and the stable treatment plan before the screening period is ≥3 months; * Historian history records of the HBV DNA \<6 and above HBV DNA \<6) HBV DNA \<minimum detection lower limit. The initial governance subjects need to meet the following conditions: * If the preliminary governance subject does not have HBSAG positive for 6 months, researchers can make the knot according to the initial diagnosis Fruit, the clinical manifestations of the subjects, and the comprehensive judgment of the family history of hepatitis B family whether it is chronic infection; * The subjects have never received the treatment of chronic hepatitis B antiviral treatment (oral nucleoside drugs and interferon) at the time of screening; * The upper limit of the normal reference value (ULN) \<Alanine aminotransferase≤ 5 × ULN (within 2 weeks before the first medication)
Exclusion criteria
Anyone who appears below will not be able to enter the group test: * Pregnancy (pregnancy test is positive) or lactating women. * Combined other virus infections such as hepatitis A virus，hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus, syphilis (those with positive syphilis antibodies, and those who are judged by researchers) and so on. * History of liver cirrhosis or before screening/screening shows significant fibrosis or liver cirrhosis; or abdominal ultrasound examination prompts suspected liver cirrhosis; past liver dysfunction history or screening period has liver dysfunction compensation For those such as ascites, hepatic brain diseases, and esophageal stomach veins, bleeding; * The subject of Hepatocellular Carcinoma (HCC) before screening or at the time of screening has a history of Hepatocellular Carcinoma (HCC), or suspected HCC; * There is a history of malignant tumor diseases within the first 5 years of screening. Except for specific menstrual resection, it can be completely cured (such as skin basal cell carcinoma, etc.). * A subject with other chronic liver diseases, including but not limited to autoimmune liver disease, alcoholic liver disease, hepatolenticular degeneration, etc. * Organization and bone marrow transplantation have been accepted in the past. * Poor thyroid disease, or clinical thyroid dysfunction (TSH abnormal T3 or T4 abnormalities); * Eye disease: Including the bottom of the eye lesions (changes in the cotton samples with symptoms of the eye) and retinal lesions. * Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, etc. * In addition to liver disease, there are obvious systemic or major diseases. * Any systemic anti -tumor (including radiation) or immunosuppressive treatment (including biomorphic inhibitors), or immunotherapies within 6 months before screening. * Blood transfusion within ≤ 2 months before screening and/or donate blood within 1 month before screening. Note: The subject must not donate blood during the entire study; * History of allergies to test medicines or its auxiliary materials; * Toll-like receptors-7, Toll-like receptors-8 receptor agonist or PD-1, PD-L1 similar drugs have been used within three months before screening. * The subject has participated in a clinical trial and accepted the test medicine for the test before the first time of the administration: 5 semi -half -life (such as known) or studying the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as such as the duration of the biological effects (such as the duration of the biological effects (such as the duration of the biological effects (such as the duration of the biological effects (such as Two times (known) or 90 days (if the elderly prevails) or 90 days (if the half -life or duration is unknown). * History or condition of cardiovascular disease: History of risk factors for risk factors of cutting -out rooms, including miracles, known long QT syndrome, heart failure, myocardial infarction, angina pectoris, or clinical significance laboratory Examination (including hypokalemia, hypercalcemia, or hypomagnesemia). Long QT syndrome or BRUGADA syndrome family history. ECG shows abnormal clinical significance. Heart rate≤45 Secondary/minutes. * Researchers believe that those should not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| At 24 weeks, the changes in serum HBSAG relative to the baseline | Up to 24 weeks | Evaluate the subject of chronic HBV infection in the early treatment/treatment of chronic HBV infection, TQ-A3334 combined with oral nucleoside (acid) drugs comparative placebo and oral nucleoside (acid) drugs, can it significantly improve the treatment for 24 weeks Serum HBSAG relative to the changes in the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse events（AEs） | Up to 48 weeks | To investigate the incidence of adverse events (AEs) during treatment |
| Severity of adverse events (AEs) | Up to 48 weeks | To study the severity of adverse events (AEs) during treatment |
| Incidence of serious adverse events (SAEs) | Up to 48 weeks | To investigate the incidence of serious adverse events (SAEs) during treatment |
| Severity of serious adverse events（SAEs） | Up to 28 weeks | To investigate the severity of serious adverse events (SAEs) during treatment |
| HBsAg<100 IU/ml and HBV DNA <20 IU/ml subject | Week 24, 48 weeks, 60 weeks, 72 weeks | The proportion of subjects of HBsAg\<100 IU/ml and HBV DNA \<20 IU/ml. |
| HBSAG self -based lines drop ≥0.5, ≥1 Log10IU/ml | Week 24, 48 weeks, 60 weeks, 72 weeks | Awarded by HBSAG's self -base line decrease ≥0.5, ≥1 Log10IU/ml. |
| The proportion of subjects of HBSAG serological removal and/or serum transformation during the study period | Week 24, 48 weeks, 60 weeks, 72 weeks | HBSAG serum science clearance and/or serum transition ratio proportion |
| The proportion of subjects of HBEAG serological removal and/or serum conversion during the study period | Week 24, 48 weeks, 60 weeks, 72 weeks | The proportion of subjects of HBEAG serological removal and/or serum transformation during the study. |
| Peak time (Tmax) | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | Time to peak blood concentration after a single dose. |
| Peak Concentration | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | The highest plasma drug concentration that can be achieved after medication. |
| Area under blood concentration-time curve (AUC) | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | The amount of drug absorbed into the human circulation after a single dose can be estimated using the area under the blood concentration-time curve. |
| Apparent volume of distribution (Vd/F) | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | When a drug reaches homeostasis in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution |
| Plasma clearance | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose. | How many milliliters of plasma can the kidneys completely clear in unit time (per minute) |
| Elimination half-life time | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | The time it takes for the plasma concentration to drop by half. |
| Peaking Time | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose. | The time required to reach peak steady-state concentration after administration. |
| Steady state maximum concentration | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | The highest blood concentration that occurs after stabilization. |
| Steady state minimal concentration | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | The lowest blood concentration that occurs after stabilization |
| Area under steady-state blood concentration-time curve | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose | After the dosage of a single agent, the amount of dosage of the blood circulation of the person can be used with blood concentration-the area of the area under the time curve. |
Countries
China
Outcome results
None listed