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)

NCT ID: NCT05905458

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2024-11-22

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).

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A: HRS9950 tablets (Low dose)

Group Type: EXPERIMENTAL

HRS9950 tablets

Intervention Type: DRUG

HRS9950 tablets, oral, once a week, low dose

Treatment group B: HRS9950 tablets (High dose)

Group Type: EXPERIMENTAL

HRS9950 tablets

Intervention Type: DRUG

HRS9950 tablets, oral, once a week, high dose

Placebo Comparator: Treatment group C

Group Type: PLACEBO_COMPARATOR

HRS9950 placebo tablets

Intervention Type: DRUG

HRS9950 placebo tablets, oral, once a week.

Interventions

HRS9950 tablets

HRS9950 tablets, oral, once a week, low dose

Intervention Type: DRUG

HRS9950 tablets

HRS9950 tablets, oral, once a week, high dose

Intervention Type: DRUG

HRS9950 placebo tablets

HRS9950 placebo tablets, oral, once a week.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

HRS9950-201

Identifier Type: -

Identifier Source: org_study_id