Hepatitis B, Chronic (CHB)Phase 2NCT07630727
Study of AHB-171 in Chronic Hepatitis B Participants
A Phase 2 study testing AHB-171 Injection in people with Hepatitis B, Chronic (CHB), run by Ausper Biopharma Co., Ltd. at 10 sites in China.
Trial summary
The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic (CHB)
- What is being tested?
- AHB-171 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 10 sitesChina
- Study dates
- 24 Jun 2026to 31 May 2029
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to fully understand and sign the informed consent form (ICF).
- Male or female participants, aged 18-65 years (inclusive).
- Body mass index (BMI) meeting the predefined eligibility range.
- Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
- At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements.
- Adopt effective contraceptive measures as required
Who cannot join
- History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
- Prior history of solid organ or hematopoietic stem cell transplantation.
- History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
- History or presence of hepatic decompensation at screening.
- History of primary liver cancer, or diagnosis/suspected liver cancer at screening.
- Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening
Show all 20Show fewer
- History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation.
- Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection).
- History of drug abuse, or alcoholism.
- Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period.
- Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening.
- Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening.
- Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period.
- Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions.
- Clinically significant abnormal electrocardiogram (ECG) at screening.
- Tested positive for HIV，HCV or active syphilis infection.
- Uncontrolled hypertension at screening.
- Clinically significant abnormal laboratory test as specified in protocol at screening.
- Currently participating in another clinical trials, or within the washout period.
- Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
AusperBio Investigational Site
Beijing, Beijing Municipality
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Changzhou, Jiangsu
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Chengdu, Sichuang
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Jilin City, Jilin
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Nanning, Guangxi
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Xiamen, Fujian
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Zhengzhou, Henan
Bella Lu, 0571-86959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
About this study
Official title: An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B
The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)
- Conditions
- Hepatitis B, Chronic (CHB)
- Being tested
- AHB-171 Injection
- Medical subject headings
- Hepatitis B, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHB-171 InjectionDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| AHB-171 in Treatment CHB | Experimental | Not described Receives: Drug: AHB-171 Injection |
| AHB-171 in Naïve CHB | Experimental | Not described Receives: Drug: AHB-171 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)
Measured: Up to 90 days
Secondary outcomes (22)
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
Measured: Up to 90 days
Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
Measured: Up to 90 days
Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi
Measured: Up to 90 days
Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit
Measured: Up to 90 days
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
Measured: Up to 90 days
Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit
Measured: Up to 90 days
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit
Measured: Up to 90 days
Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit
Measured: Up to 90 days
Absolute or log change from baseline for HBsAg at each visit
Measured: Up to 90 days
Absolute or log change from baseline for HBV RNA at each visit
Measured: Up to 90 days
Absolute or log change from baseline for HBcrAg at each visit
Measured: Up to 90 days
Absolute or log change from baseline for HBeAg at each visit
Measured: Up to 90 days
Absolute or log change from baseline for HBeAb at each visit
Measured: Up to 90 days
Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization
Measured: Up to 90 days
Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
CTCAE will be used to describe severity.
Measured: Up to 90 days
Proportion of participants with clinically significant abnormalities in laboratory tests
Measured: Up to 90 days
Proportion of participants with clinically significant abnormalities in ECG
Measured: Up to 90 days
Proportion of participants with clinically significant abnormalities in physical examinations and vital signs
Measured: Up to 90 days
Changes in ECG from baseline
Measured: Up to 90 days
Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL
Measured: Up to 90 days
Plasma concentration of AHB-171 at different time points
Measured: Up to 90 days
Proportion of participants with detectable anti-drug antibody (ADA)
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start24 Jun 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, Chronic (CHB)Studies of the same condition, open and under way.
- More trials run by Ausper Biopharma 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630727
- Sponsor's protocol ID
- AB-17-8003
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 21 Jul 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07630727
- Acronym / sponsor ID
- AB-17-8003
- Conditions
- Hepatitis B, Chronic (CHB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 5 Jun 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.
The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHB-171 in Treatment CHB | Experimental | Drug: AHB-171 Injection |
| AHB-171 in Naïve CHB | Experimental | Drug: AHB-171 Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to fully understand and sign the informed consent form (ICF).
- Male or female participants, aged 18-65 years (inclusive).
- Body mass index (BMI) meeting the predefined eligibility range.
- Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
- At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements.
Key exclusion criteria (20 listed)
- History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
- Prior history of solid organ or hematopoietic stem cell transplantation.
- History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
- History or presence of hepatic decompensation at screening.
- History of primary liver cancer, or diagnosis/suspected liver cancer 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-171 InjectionSubcutaneous injection | Drug | AHB-171 in Naïve CHB, AHB-171 in Treatment CHB |
Primary outcome
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)
Time frame: Up to 90 days
22 secondary outcomes
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
Time frame: Up to 90 days
Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
Time frame: Up to 90 days
Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi
Time frame: Up to 90 days
Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit
Time frame: Up to 90 days
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
Time frame: Up to 90 days
Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit
Time frame: Up to 90 days
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit
Time frame: Up to 90 days
Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBsAg at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBV RNA at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBcrAg at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBeAg at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBeAb at each visit
Time frame: Up to 90 days
Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization
Time frame: Up to 90 days
Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
Time frame: Up to 90 days
Proportion of participants with clinically significant abnormalities in laboratory tests
Time frame: Up to 90 days
Proportion of participants with clinically significant abnormalities in ECG
Time frame: Up to 90 days
Proportion of participants with clinically significant abnormalities in physical examinations and vital signs
Time frame: Up to 90 days
Changes in ECG from baseline
Time frame: Up to 90 days
Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL
Time frame: Up to 90 days
Plasma concentration of AHB-171 at different time points
Time frame: Up to 90 days
Proportion of participants with detectable anti-drug antibody (ADA)
Time frame: Up to 90 days
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 21 Jul 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.
10 sites 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-171 Injection in people with Hepatitis B, Chronic (CHB), run by Ausper Biopharma Co., Ltd. at 10 sites 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 20 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 21 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 10 sites 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?
Contact Bella Lu (0571-86959519, clinicaltrial@ausperbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL) (time frame: Up to 90 days). 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 21 Jul 2026.