A Multicenter, Randomized, Open, Parallel-designed 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

Phase 2

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: HRS-5635 Injection

• Registration Number: NCT06425341
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Status Verified: 2024-06
• Study Start: 2024-06-14
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-05-15
• Study Completion: 2026-09-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

1. Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 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 4 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. History of solid organ transplantation or hematopoietic stem cell transplantation;
4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
5. Malignant tumors were diagnosed within 5 years prior to randomization；
6. Infection requiring intervention within 2 weeks prior to randomization;
7. 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;
8. Laboratory tests during the screening period were obviously abnormal;
9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
11. Participated in clinical study of other drugs (received experimental drugs);
12. Pregnant or nursing women;
13. Allergic to a drug ingredient or component;
14. Other reasons for ineligibility as judged by the investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-5635 Injection dose 1	HRS-5635 Injection	-
HRS-5635 Injection dose 4	HRS-5635 Injection	-
HRS-5635 Injection dose 2	HRS-5635 Injection	-
HRS-5635 Injection dose 3	HRS-5635 Injection	-

Primary Outcome Measures

Name	Time	Method
PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12	Week 12
PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48	Week 48

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in mean log10 serum hepatitis B surface antigen levels	Pre-specified time points up to 72 weeks
Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen	Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss	Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion	Pre-specified time points up to 72 weeks
Proportion of subjects with hepatitis B e-antigen loss	Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion	Pre-specified time points up to 72 weeks
Proportion of subjects with virologic breakthrough	Pre-specified time points up to 72 weeks
Proportion of subjects with drug resistance	Pre-specified time points up to 72 weeks

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China