This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.
Subjects voluntarily participate in this study and sign informed consent;
Male and female ≥18 years old and ≤65 years old;
Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18~28 kg/m2;
Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml ≤ HBsAg quantification ≤ 5000 IU/ml;
Pregnant and lactating women;
Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
Individuals with a history of active pathological bleeding or a tendency towards bleeding;
Parallel
TQA3038 injection/placebo
DrugTQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
Nucleotide drugs Control group
DrugNucleotide drugs are nucleoside reverse transcriptase inhibitors.
Adverse events (AEs)
The incidence of adverse events (AEs) during treatment.
Serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) during treatment.
Hepatitis B virus surface antigen (HbsAg)
Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.
Time to Reach Maximum Plasma Concentration (Tmax)
Time to reach Cmax of TQA3038 and its metabolite in plasma.
Maximum Plasma Concentration (Cmax)
Maximum concentration of TQA3038 and its metabolite in plasma.
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time.
Volume of distribution (Vd/F)
Volume of distribution (Vd/F) of TQA3038 in Plasma.
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