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

NCT06425341 | Recruiting Phase 2

• 1 other identifier: HRS-5635-201
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (4)

• 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

• PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48

  Week 48

• PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48

  Week 48

Secondary Outcomes (10)

• 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

Study Arms (9)

HRS-5635 Injection dose 1

EXPERIMENTAL

Drug: HRS-5635 Injection

HRS-5635 Injection dose 2

EXPERIMENTAL

Drug: HRS-5635 Injection

HRS-5635 Injection dose 3

EXPERIMENTAL

Drug: HRS-5635 Injection

HRS-5635 Injection dose 4

EXPERIMENTAL

Drug: HRS-5635 Injection

HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection

EXPERIMENTAL

Drug: HRS-5635 Injection (low dose) and Peg-IFN-α

HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection

EXPERIMENTAL

Drug: HRS-5635 Injection (high dose) and Peg-IFN-α

Peg-IFN-α, administered by subcutaneous injection

PLACEBO COMPARATOR

Drug: Peg-IFN-α

HRS-5635 Injection with Peg-IFN-α（Part C）

EXPERIMENTAL

Drug: HRS-5635 Injection with Peg-IFN-α

HRS-5635 Injection（Part D）

EXPERIMENTAL

Drug: HRS-5635 Injection

Interventions

HRS-5635 Injection DRUG

HRS-5635 Injection low dose administered by subcutaneous injection

HRS-5635 Injection dose 1

HRS-5635 Injection (low dose) and Peg-IFN-α DRUG

HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection

HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection

HRS-5635 Injection (high dose) and Peg-IFN-α DRUG

HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection

HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection

Peg-IFN-α DRUG

Peg-IFN-α, administered by subcutaneous injection

Peg-IFN-α, administered by subcutaneous injection

HRS-5635 Injection with Peg-IFN-α DRUG

HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection

HRS-5635 Injection with Peg-IFN-α（Part C）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
• Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
• Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
• 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;
• Need to take effective contraceptive measures；
• Volunteer to sign an informed consent.

You may not qualify if:

• 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;
• With autoimmune disease;
• History of solid organ transplantation or hematopoietic stem cell transplantation;
• Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
• Malignant tumors were diagnosed within 5 years prior to randomization；
• Infection requiring intervention within 2 weeks prior to randomization;
• 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;
• Laboratory tests during the screening period were obviously abnormal;
• Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
• History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
• Participated in clinical study of other drugs (received experimental drugs);
• Pregnant or nursing women;
• Allergic to a drug ingredient or component;
• Other reasons for ineligibility as judged by the investigators.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaopeng Wang

CONTACT

0518-82342973; xiaopeng.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, random, open, parallel design

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): January 19, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-07

Locations

CN (1)