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)

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)

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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: HRS9950 tablets; Drug: HRS9950 tablets; Drug: HRS9950 placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS9950 tablets (Low dose)	Drug: HRS9950 tablets; HRS9950 tablets, oral, once a week, low dose; Drug: HRS9950 tablets; HRS9950 tablets, oral, once a week, high dose
Experimental: Treatment group B: HRS9950 tablets (High dose)	Drug: HRS9950 tablets; HRS9950 tablets, oral, once a week, low dose; Drug: HRS9950 tablets; HRS9950 tablets, oral, once a week, high dose
Placebo Comparator: Placebo Comparator: Treatment group C	Drug: HRS9950 placebo tablets; HRS9950 placebo tablets, oral, once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24	Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
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 serum hepatitis B surface antigen loss	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 e-antigen seroconversion	Pre-specified time points up to 48 weeks
Proportion of subjects with virologic breakthrough	Pre-specified time points up to 48 weeks
Proportion of subjects with drug resistance	Pre-specified time points up to 48 weeks

Collaborators and Investigators

• Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Actual): November 22, 2024
• Study Completion (Actual): November 22, 2024

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis A; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: HRS9950-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No