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)

Phase 2

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: HRS9950 tablets; Drug: HRS9950 placebo tablets

• Registration Number: NCT05905458
• Lead Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Study Start: 2023-07-28
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A: HRS9950 tablets (Low dose)	HRS9950 tablets	-
Treatment group B: HRS9950 tablets (High dose)	HRS9950 tablets	-
Placebo Comparator: Treatment group C	HRS9950 placebo tablets	-

Primary Outcome Measures

Name	Time	Method
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24	Week 24

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with serum hepatitis B e-antigen seroconversion	Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion	Pre-specified time points up to 48 weeks
Proportion of subjects with hepatitis B e-antigen loss	Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen loss	Pre-specified time points up to 48 weeks
Proportion of subjects with drug resistance	Pre-specified time points up to 48 weeks
Changes from baseline in mean log10 serum hepatitis B surface antigen levels	Pre-specified time points up to 48 weeks
Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen	Pre-specified time points up to 48 weeks
Proportion of subjects with virologic breakthrough	Pre-specified time points up to 48 weeks

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China