A Phase II Clinical Study of the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)

Chengdu Suncadia Medicine

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: HRS9950 tablets; Drug: HRS9950 placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05905458

HRS9950-201

Details and patient eligibility

About

To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the body mass index standard among 18.0 to 30 kg/m2;；
2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 12 weeks before randomization;
5. Need to take effective contraceptive measures；
6. Volunteer to sign an informed consent.

Exclusion criteria

1. 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;
2. With autoimmune disease;
3. With poorly-controlled diabetes, thyroid disease requiring clinical intervention, clinically significant thyroid dysfunction, neurological or psychiatric disorder, severe lung disease, chronic renal disease or retinopathy;
4. History of solid organ transplantation or hematopoietic stem cell transplantation;
5. Poorly-controlled hypertension, clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
6. Malignant tumors were diagnosed within 5 years prior to randomization；
7. Infection requiring intervention within 4 weeks prior to randomization;
8. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
9. Laboratory tests during the screening period were obviously abnormal;
10. Prolonged ECG QTc interval (male > 450ms, female > 470ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;
11. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
12. Participated in clinical study of other drugs (received experimental drugs);
13. Pregnant or nursing women;
14. Allergic to a drug ingredient or component;
15. Other reasons for ineligibility as judged by the investigators.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

Treatment group A: HRS9950 tablets (Low dose)

Experimental group

Treatment:

Drug: HRS9950 tablets

Drug: HRS9950 tablets

Treatment group B: HRS9950 tablets (High dose)

Experimental group

Treatment:

Drug: HRS9950 tablets

Drug: HRS9950 tablets

Placebo Comparator: Treatment group C

Placebo Comparator group

Treatment:

Drug: HRS9950 placebo tablets