Chronic Hepatitis BPhase 2NCT06993480
A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
A Phase 2 study testing AHB-137 in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- AHB-137
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 27 Nov 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntarily participated in the study and signed an informed consent form;
- Aged between 18 and 55 years at the time of signing the informed consent form;
- Body mass index (BMI) within the range of 18-30 kg/ m2;
- HBeAg negative or positive at screening;
- HBsAg or HBV DNA positive for at least 6 months;
- Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening;
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- 100 IU/mL < HBsAg ≤ 3000 IU/mL and HBV DNA < 100 IU/mL at screening;
- Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
- Effective contraception as required.
Who cannot join
- Clinically significant abnormalities other than a history of CHB infection;
- Concomitant clinically significant other liver diseases;
- Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
- Liver stiffness value (LSM) > 9.0 kPa at screening;
- Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening;
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- Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis;
- Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage;
- History of extrahepatic disease possibly related to HBV immune status;
- Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy;
- Receiving or using any interferon-containing therapy within 12 months prior to screening;
- History of malignancy within 5 years prior to screening or being evaluated for possible malignancy;
- Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant);
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
- Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening;
- Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- Received any antisense oligonucleotides (ASO) or using any small molecule interfering ribonucleic acid (siRNA) drug within 12 months prior to screening;
- Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment;
- Obviously abnormal laboratory test results;
- History of vasculitis or signs and symptoms of underlying vasculitis;
- Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
About this study
Official title: A Single-Center, Open-Label Phase II Clinical Study to Evaluate the Antiviral Activity and Immune Responses of AHB-137 Injection in Participants With CHB Treated With Nucleos (t) Ide Analogues
This study is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
- Conditions
- Chronic Hepatitis B
- Being tested
- AHB-137
- Keywords
- Hepatitis B, Chronic
- 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.
AHB-137Drug
AHB-137 300 mg will be injected subcutaneously once a week (total 24 weeks).
| Study group | Role | What they receive |
|---|---|---|
| AHB-137 | Experimental | AHB-137 will be injected subcutaneously. Receives: Drug: AHB-137 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion.
Measured: Up to 24 weeks
Secondary outcomes (16)
Number and percentage of participants with serum HBsAg < LOD and/or HBV DNA < LLOQ.
Measured: Up to 72 weeks
Proportion of participants maintaining sustained response;
Measured: Up to 48 weeks
The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline;
Measured: Up to 72 weeks
The changes in the phenotype of liver immune cells compared to baseline;
Measured: Up to 72 weeks
The changes of peripheral blood cytokines compared to baseline;
Measured: Up to 72 weeks
The changes of peripheral blood immune cell phenotypes compared to baseline;
Measured: Up to 72 weeks
The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBeAg, HBeAb compared to baseline;
Measured: Up to 72 weeks
The changes in peripheral blood metabolomics compared to baseline;
Measured: Up to 72 weeks
The changes in peripheral blood proteomics compared to baseline;
Measured: Up to 72 weeks
The changes in liver metabolomics compared to baseline, if applicable ;
Measured: Up to 72 weeks
AHB-137 drug concentrations, and metabolite profiling, if applicable;
Measured: Up to 72 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA);
Measured: Up to 72 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Measured: Up to 72 weeks
After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was below the detection limit (0.05 IU/mL), with HBeAg being negative, with or without the presence of HBsAg.
Measured: Up to 72 weeks.
After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was less than 10 IU/mL.
Measured: Up to 72 weeks
Whether the NA treatment discontinuation criteria have been met during the assessment of NA treatment discontinuation.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 Jul 2025
- Primary completion27 Jul 2027 (estimated)
- Study completion27 Nov 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dazhi Zhang, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993480
- Sponsor's protocol ID
- AB-10-8005
- Status last verified
- Aug 2026
- First submitted
- 16 May 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Phase II Clinical Study to Evaluate the Antiviral Activity and Immune Responses of AHB-137 Injection in Participants With CHB Treated With Nucleos (t) Ide Analogues
- ClinicalTrials.gov ID
- NCT06993480
- Acronym / sponsor ID
- AB-10-8005
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 27 Nov 2027 (estimated)
- First posted
- 28 May 2025 (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 a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHB-137 | Experimental | Drug: AHB-137AHB-137 will be injected subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Voluntarily participated in the study and signed an informed consent form;
- Aged between 18 and 55 years at the time of signing the informed consent form;
- Body mass index (BMI) within the range of 18-30 kg/ m2;
- HBeAg negative or positive at screening;
- HBsAg or HBV DNA positive for at least 6 months;
Key exclusion criteria (21 listed)
- Clinically significant abnormalities other than a history of CHB infection;
- Concomitant clinically significant other liver diseases;
- Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
- Liver stiffness value (LSM) > 9.0 kPa at screening;
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 |
|---|---|---|
| AHB-137AHB-137 300 mg will be injected subcutaneously once a week (total 24 weeks). | Drug | AHB-137 |
Primary outcome
Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion.
Time frame: Up to 24 weeks
16 secondary outcomes
Number and percentage of participants with serum HBsAg < LOD and/or HBV DNA < LLOQ.
Time frame: Up to 72 weeks
Proportion of participants maintaining sustained response;
Time frame: Up to 48 weeks
The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline;
Time frame: Up to 72 weeks
The changes in the phenotype of liver immune cells compared to baseline;
Time frame: Up to 72 weeks
The changes of peripheral blood cytokines compared to baseline;
Time frame: Up to 72 weeks
The changes of peripheral blood immune cell phenotypes compared to baseline;
Time frame: Up to 72 weeks
The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBeAg, HBeAb compared to baseline;
Time frame: Up to 72 weeks
The changes in peripheral blood metabolomics compared to baseline;
Time frame: Up to 72 weeks
The changes in peripheral blood proteomics compared to baseline;
Time frame: Up to 72 weeks
The changes in liver metabolomics compared to baseline, if applicable ;
Time frame: Up to 72 weeks
AHB-137 drug concentrations, and metabolite profiling, if applicable;
Time frame: Up to 72 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA);
Time frame: Up to 72 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Time frame: Up to 72 weeks
After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was below the detection limit (0.05 IU/mL), with HBeAg being negative, with or without the presence of HBsAg.
Time frame: Up to 72 weeks.
After discontinuation of all chronic hepatitis B treatments for 24 weeks, HBV DNA was below the limit of quantification (LLOQ), and HBsAg was less than 10 IU/mL.
Time frame: Up to 72 weeks
Whether the NA treatment discontinuation criteria have been met during the assessment of NA treatment discontinuation.
Time frame: 48 weeks
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dazhi Zhang principal investigator
The Second Affiliated Hospital of Chongqing Medical University
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 AHB-137 in people with Chronic Hepatitis B, run by Ausper Biopharma 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 9 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion. (time frame: Up to 24 weeks). 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 10 Aug 2026.