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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: HRS-5635 Injection; Drug: HRS-5635 Injection; Drug: HRS-5635 Injection; Drug: HRS-5635 Injection; Drug: HRS-5635 Injection (low dose) and Peg-IFN-α; Drug: HRS-5635 Injection (high dose) and Peg-IFN-α; Drug: Peg-IFN-α; Drug: HRS-5635 Injection; Drug: HRS-5635 Injection with Peg-IFN-α

• Study Type: Interventional
• Enrollment (Estimated): 369
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaopeng Wang; Phone Number: 0518-82342973; Email: xiaopeng.wang@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital
      • Contact: Jinlin Hou; Phone Number: 020-62787432; Email: jlhousmu@163.com

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-5635 Injection dose 1	Drug: HRS-5635 Injection; HRS-5635 Injection low dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection medium dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection high dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection lowest dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection, administered by subcutaneous injection
Experimental: HRS-5635 Injection dose 2	Drug: HRS-5635 Injection; HRS-5635 Injection low dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection medium dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection high dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection lowest dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection, administered by subcutaneous injection
Experimental: HRS-5635 Injection dose 3	Drug: HRS-5635 Injection; HRS-5635 Injection low dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection medium dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection high dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection lowest dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection, administered by subcutaneous injection
Experimental: HRS-5635 Injection dose 4	Drug: HRS-5635 Injection; HRS-5635 Injection low dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection medium dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection high dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection lowest dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection, administered by subcutaneous injection
Experimental: HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection	Drug: HRS-5635 Injection (low dose) and Peg-IFN-α; HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
Experimental: HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection	Drug: HRS-5635 Injection (high dose) and Peg-IFN-α; HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
Placebo Comparator: Peg-IFN-α, administered by subcutaneous injection	Drug: Peg-IFN-α; Peg-IFN-α, administered by subcutaneous injection
Experimental: HRS-5635 Injection with Peg-IFN-α（Part C）	Drug: HRS-5635 Injection with Peg-IFN-α; HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
Experimental: HRS-5635 Injection（Part D）	Drug: HRS-5635 Injection; HRS-5635 Injection low dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection medium dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection high dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection lowest dose administered by subcutaneous injection; Drug: HRS-5635 Injection; HRS-5635 Injection, administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Proportion of subjects who meet the criteria for stopping NA therapy	From 48 weeks to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss	Week 48

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): January 19, 2027

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic; Anti-Infective Agents; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antiviral Agents; Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha
• Other Study ID Numbers: HRS-5635-201

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