Chronic Hepatitis BPhase 2NCT06425341
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 Phase 2 study testing HRS-5635 Injection, HRS-5635 Injection (low dose) and Peg-IFN-α and HRS-5635 Injection (high dose) and Peg-IFN-α in people with Chronic Hepatitis B, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HRS-5635 Injection, HRS-5635 Injection (low dose) and Peg-IFN-α and HRS-5635 Injection (high dose) and Peg-IFN-α
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2024to 19 Jan 2027
- Phase
- Phase 2
- 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
- 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.
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；
- Infection requiring intervention within 2 weeks prior to randomization;
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- 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.
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
Guangzhou, Guangdong, 510515
Jinlin Hou, 020-62787432, jlhousmu@163.com
About this study
Official title: 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- HRS-5635 Injection, HRS-5635 Injection (low dose) and Peg-IFN-α, HRS-5635 Injection (high dose) and Peg-IFN-α, Peg-IFN-α, HRS-5635 Injection with Peg-IFN-α
- Medical subject headings
- Hepatitis B, Chronic
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 low dose administered by subcutaneous injection
HRS-5635 InjectionDrug
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 InjectionDrug
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 InjectionDrug
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection (low dose) and Peg-IFN-αDrug
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection (high dose) and Peg-IFN-αDrug
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
Peg-IFN-αDrug
Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection with Peg-IFN-αDrug
HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 InjectionDrug
HRS-5635 Injection, administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| HRS-5635 Injection dose 1 | Experimental | Not described Receives: Drug: HRS-5635 Injection |
| HRS-5635 Injection dose 2 | Experimental | Not described Receives: Drug: HRS-5635 Injection |
| HRS-5635 Injection dose 3 | Experimental | Not described Receives: Drug: HRS-5635 Injection |
| HRS-5635 Injection dose 4 | Experimental | Not described Receives: Drug: HRS-5635 Injection |
| HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection | Experimental | Not described Receives: Drug: HRS-5635 Injection (low dose) and Peg-IFN-α |
| HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection | Experimental | Not described Receives: Drug: HRS-5635 Injection (high dose) and Peg-IFN-α |
| Peg-IFN-α, administered by subcutaneous injection | Placebo comparator | Not described Receives: Drug: Peg-IFN-α |
| HRS-5635 Injection with Peg-IFN-α（Part C） | Experimental | Not described Receives: Drug: HRS-5635 Injection with Peg-IFN-α |
| HRS-5635 Injection（Part D） | Experimental | Not described Receives: Drug: HRS-5635 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
Measured: Week 12
PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Measured: Week 48
PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Measured: Week 48
PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Measured: Week 48
Secondary outcomes (10)
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Measured: 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
Measured: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss
Measured: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Measured: Pre-specified time points up to 72 weeks
Proportion of subjects with hepatitis B e-antigen loss
Measured: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Measured: Pre-specified time points up to 72 weeks
Proportion of subjects with virologic breakthrough
Measured: Pre-specified time points up to 72 weeks
Proportion of subjects with drug resistance
Measured: Pre-specified time points up to 72 weeks
Proportion of subjects who meet the criteria for stopping NA therapy
Measured: From 48 weeks to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start6 Jun 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, random, open, parallel design
- Masking
- None (open label)
- Enrolment
- 369 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
- NCT06425341
- Sponsor's protocol ID
- HRS-5635-201
- Status last verified
- Jul 2025
- First submitted
- 17 May 2024
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06425341
- Acronym / sponsor ID
- HRS-5635-201
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 19 Jan 2027 (estimated)
- First posted
- 22 May 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Multi-center, random, open, parallel design
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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；
Key exclusion criteria (14 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 low dose administered by subcutaneous injection | Drug | HRS-5635 Injection dose 1 |
| HRS-5635 InjectionHRS-5635 Injection medium dose administered by subcutaneous injection | Drug | HRS-5635 Injection dose 2 |
| HRS-5635 InjectionHRS-5635 Injection high dose administered by subcutaneous injection | Drug | HRS-5635 Injection dose 3 |
| HRS-5635 InjectionHRS-5635 Injection lowest dose administered by subcutaneous injection | Drug | HRS-5635 Injection dose 4 |
| HRS-5635 Injection (low dose) and Peg-IFN-αHRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection | Drug | HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection |
| HRS-5635 Injection (high dose) and Peg-IFN-αHRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection | Drug | HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection |
| Peg-IFN-αPeg-IFN-α, administered by subcutaneous injection | Drug | Peg-IFN-α, administered by subcutaneous injection |
| HRS-5635 Injection with Peg-IFN-αHRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection | Drug | HRS-5635 Injection with Peg-IFN-α（Part C） |
| HRS-5635 InjectionHRS-5635 Injection, administered by subcutaneous injection | Drug | HRS-5635 Injection（Part D） |
Primary outcome
PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
Time frame: Week 12
PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time frame: Week 48
PartC：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time frame: Week 48
PartD：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time frame: Week 48
10 secondary outcomes
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Time frame: 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
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with hepatitis B e-antigen loss
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with virologic breakthrough
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with drug resistance
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects who meet the criteria for stopping NA therapy
Time frame: From 48 weeks to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss
Time frame: Week 48
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 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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 2 study testing HRS-5635 Injection, HRS-5635 Injection (low dose) and Peg-IFN-α and HRS-5635 Injection (high dose) and Peg-IFN-α in people 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 14 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 17 Nov 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12 (time frame: Week 12). The study lists 4 primary outcomes in all. 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 17 Nov 2025.