Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis BPhase 3NCT07606950
Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
A Phase 3 study testing HRS-5635 Injection in people with Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
- What is being tested?
- HRS-5635 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2026to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- HBeAg negative at screening;
- 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.
Who cannot join
- 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；
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangzhou, 510515
Jinlin Hou
About this study
Official title: 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.
- Being tested
- HRS-5635 Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5635 InjectionDrug
HRS-5635 Injection, administered by subcutaneous injection;
PlaceboDrug
Placebo, administered by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| HRS-5635 Injection | Experimental | Not described Receives: Drug: HRS-5635 Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy
Measured: 24 weeks after discontinuation of all CHB treatment
Secondary outcomes (15)
Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL
Measured: 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
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with sustained HBV DNA suppression
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg < 100 IU/mL
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg < 10 IU/mL
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Changes from baseline in mean log10 HBsAg levels
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg loss
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBsAg seroconversion
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with HBeAb positive
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with virologic breakthrough
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Percentage of participants with drug resistance
Measured: 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
Measured: Week 72 and Week 96
Relapse rate after discontinuation of NAs therapy
Measured: Up to 24 weeks after discontinuation of NAs treatment
Treatment-emergent adverse events
Measured: Up to 24 weeks after discontinuation of NAs treatment
Percentage of participants with detectable anti-drug antibodies
Measured: Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start17 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606950
- Sponsor's protocol ID
- HRS-5635-301
- Status last verified
- Mar 2026
- First submitted
- 19 May 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07606950
- Acronym / sponsor ID
- HRS-5635-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-5635 Injection | Experimental | Drug: HRS-5635 Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- HBeAg negative at screening;
- 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；
Key exclusion criteria (13 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-5635 InjectionHRS-5635 Injection, administered by subcutaneous injection; | Drug | HRS-5635 Injection |
| PlaceboPlacebo, administered by subcutaneous injection. | Drug | Placebo |
Primary outcome
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
15 secondary outcomes
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
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
Percentage of participants with sustained HBV DNA suppression
Time frame: 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
Percentage of participants with HBsAg < 10 IU/mL
Time frame: 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
Percentage of participants with HBsAg loss
Time frame: 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
Percentage of participants with HBeAb positive
Time frame: 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
Percentage of participants with drug resistance
Time frame: 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
Relapse rate after discontinuation of NAs therapy
Time frame: Up to 24 weeks after discontinuation of NAs treatment
Treatment-emergent adverse events
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS-5635 Injection in people with Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaopeng Wang (0518-82342973, xiaopeng.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.