Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

July 23, 2026 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-5635 Injection in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Principal Investigator:
          • Jinlin Hou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
  2. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
  3. HBeAg negative at screening;
  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. 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;
  7. Laboratory tests during the screening period were obviously abnormal;
  8. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
  9. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
  10. Participated in clinical study of other drugs (received experimental drugs);
  11. Pregnant or nursing women;
  12. Allergic to a drug ingredient or component;
  13. Other reasons for ineligibility as judged by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo, administered by subcutaneous injection.
Experimental: HRS-5635 Injection
Drug: HRS-5635 Injection
HRS-5635 Injection, administered by subcutaneous injection;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy
Time Frame: 24 weeks after discontinuation of all CHB treatment
24 weeks after discontinuation of all CHB treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with sustained HBV DNA suppression and HBsAg < 10 IU/mL
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with sustained HBV DNA suppression
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg < 100 IU/mL
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg < 10 IU/mL
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Changes from baseline in mean log10 HBsAg levels
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg loss
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg seroconversion
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBeAb positive
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with virologic breakthrough
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with drug resistance
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Relapse rate after discontinuation of NAs therapy
Time Frame: Up to 24 weeks after discontinuation of NAs treatment
Up to 24 weeks after discontinuation of NAs treatment
Treatment-emergent adverse events
Time Frame: Up to 24 weeks after discontinuation of NAs treatment
Up to 24 weeks after discontinuation of NAs treatment
Percentage of participants with detectable anti-drug antibodies
Time Frame: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants who meet the criteria for stopping nucleos(t)ide analogue (NA) therapy
Time Frame: Week 72 and Week 96
Week 72 and Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-5635-301

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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