A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.
Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
With autoimmune disease;
History of solid organ transplantation or hematopoietic stem cell transplantation;
Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
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Treatment groupsSee each treatment group below.