Placebo
DrugPlacebo contains no active substance.
NCT Number: NCT06706310
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.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Phase 2
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Those who meet all the selected standards below can enter the group test:
Those who have been treated after treatment need to meet the following conditions:
The initial governance subjects need to meet the following conditions:
Exclusion criteria
Anyone who appears below will not be able to enter the group test:
Placebo contains no active substance.
Inhibit viral replication.
Inhibit viral replication.
Time frame: 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
Time frame: Up to 48 weeks
To investigate the incidence of adverse events (AEs) during treatment
Time frame: Up to 48 weeks
To study the severity of adverse events (AEs) during treatment
Time frame: Up to 48 weeks
To investigate the incidence of serious adverse events (SAEs) during treatment
Time frame: Up to 28 weeks
To investigate the severity of serious adverse events (SAEs) during treatment
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
The proportion of subjects of HBsAg<100 IU/ml and HBV DNA <20 IU/ml.
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
Awarded by HBSAG's self -base line decrease ≥0.5, ≥1 Log10IU/ml.
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
HBSAG serum science clearance and/or serum transition ratio proportion
Time frame: Week 24, 48 weeks, 60 weeks, 72 weeks
The proportion of subjects of HBEAG serological removal and/or serum transformation during the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
Evaluate TQ-A3334 Tablets Combined Nucleoside (Acid) Analogs in the Initial Treatment/Chronic Hepatitis B Virus (HBV) Infection Subjects of Chronic HBV Infection
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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