Hepatitis B, ChronicPhase 2ASPIRE-201NCT07370207
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
A Phase 2 study testing AHB-137 in people with Hepatitis B, Chronic, run by AusperBio Therapeutics Inc. at 10 sites in 7 countries.
Trial summary
This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- 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
- 84 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 6 Mar 2026to 31 Dec 2028
- 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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.
- Body mass index (BMI) ≤35 kg/m².
- Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.
- Hepatitis B e antigen (HBeAg) negative at Screening.
- Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
Show all 12Show fewer
- HBV DNA below the lower limit of quantification (LLOQ) at Screening.
- Hepatitis B surface antigen (HBsAg) level >100 IU/mL and ≤3,000 IU/mL at Screening.
- Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) at Screening.
- Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.
- Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose.
- Male and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137.
Who cannot join
- Participants will be excluded from the study if any of the following criteria apply:
- Clinically significant disease other than chronic hepatitis B virus (HBV) infection, as documented in medical history or identified on physical examination, including but not limited to acute coronary syndrome within 6 months prior to Screening, significant or unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, or prior solid organ or bone marrow transplant
- Concomitant clinically significant liver disease, including but not limited to viral hepatitis caused by other pathogens, hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, drug-induced liver injury, or current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, hepatorenal syndrome, or variceal hemorrhage).
- Any severe infection (other than chronic HBV infection) within 1 month prior to randomization and/or requiring intravenous anti-infective therapy.
- History of immune thrombocytopenia.
- Current suspected liver cirrhosis and/or evidence of cirrhosis defined as liver stiffness measurement (LSM) >9 kPa by FibroScan® or equivalent imaging modality (e.g., ultrasound elastography).
Show all 35Show fewer
- History of liver cirrhosis defined by liver biopsy or by LSM >12 kPa by FibroScan® or equivalent imaging modality.
- Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
- History of extrahepatic diseases potentially associated with HBV infection, including but not limited to nephrotic syndrome, any form of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, or uncontrolled hypertension.
- Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible.
- Abnormal laboratory values at Screening meeting any of the following criteria:
- Serum albumin <3.5 g/dL
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² calculated using the CKD-EPI equation (or JSN-CKDI equation for participants in Japan)
- International normalized ratio (INR) >1.25
- Platelet count <125 × 10⁹/L
- Total bilirubin >1.5 × upper limit of normal (ULN). Participants with benign unconjugated hyperbilirubinemia (Gilbert's syndrome) may be enrolled if deemed eligible by the Investigator
- Urine albumin-to-creatinine ratio (uACR) >0.3 mg/mg (300 mg/g) on two consecutive measurements following a positive or weakly positive urine protein result on routine urinalysis
- Borderline positive or positive antineutrophil cytoplasmic antibody (ANCA) results requiring further evaluation (MPO-ANCA and PR3-ANCA). Eligibility requires review of complete medical history and confirmation of no past or current vasculitic, inflammatory, or autoimmune disease by the Sponsor or Sponsor-designated Medical Monitor
- History of vasculitis or presence of signs or symptoms suggestive of vasculitis (e.g., vasculitic rash, skin ulceration, unexplained recurrent hematuria), or history or presence of diseases associated with vasculitis (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
- History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded.
- History of hypersensitivity or allergy to any component of the investigational product (IP).
- Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor.
- Current alcohol or substance abuse that, in the Investigator's judgment, may interfere with study participation or compliance.
- Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and/or in vitro fertilization during the study.
- Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within:
- Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or
- Six months, if neither half-life nor duration of effect is known
- Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies.
- Any of the following prior or concomitant therapies:
- Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2 weeks) or topical/inhaled corticosteroids
- Interferon therapy within 12 months prior to first dose
- Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster
- Current treatment with bulevirtide
- Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin, unless the Investigator determines the medication can be safely discontinued prior to first IP administration. Participants taking low-dose aspirin must agree to discontinue use during the study if protocol-specified conditions are met.
- Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.
Trial locations and contacts
10 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Toll Free-North America contact
10 sites in 7 countries
Taiwan3 sites, 3 recruiting
- Recruiting
Chiayi Christian Hospital
Chiayi City, 60002
- Recruiting
E-DA Hospital
Kaohsiung City, 82445
- Recruiting
National Taiwan University Hospital
Taipei, 100
Japan2 sites, 2 recruiting
- Recruiting
Japanese Red Cross Musashino Hospital
Musashino, Tokyo, 180-0023
- Recruiting
National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655
Australia1 site, 1 recruiting
- Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research
Grafton, Auckland, 1010
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital - Singapore
Singapore, 119074
About this study
Official title: A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)Ide Analogue-treated Participants With HBeAg Negative Chronic Hepatitis B in the Asia Pacific Region
This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).
- Conditions
- Hepatitis B, Chronic
- Being tested
- AHB-137
- Keywords
- Hepatitis, Chronic Hepatitis, Chronic Hepatitis B, Hepatitis B, Hepatitis B, Chronic, Hepatitis B Virus, hepatitis B virus e-antigen, AHB-137, Nucleos(t)ide analog, Nucleos(t)ide analogue, Antisense Oligonucleotide, Blood-Borne Infections, Communicable Diseases, Infections, DNA Virus Infections, Virus Diseases, Hepatitis, Viral, Human, Liver Diseases, Digestive System Diseases, Chronic Disease
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Hepatitis, Chronic, Hepatitis B, Blood-Borne Infections, Communicable Diseases, Infections, DNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHB-137Drug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: AHB-137 + 2 LDs | Experimental | AHB-137 300 mg subcutaneous (SC) weekly for 24 weeks with 2 loading doses (LDs) on Days 4 and 11 Receives: Drug: AHB-137 |
| Arm B: AHB-137 + 3 LDs | Experimental | AHB-137 300 mg SC weekly for 24 weeks with 3 LDs on Days 4, 11, and 18 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 sustained response post AHB-137 treatment
Sustained response defined as hepatitis B surface antigen (HBsAg) level below the limit of detection (LOD, 0.05 international units [IU]/mL) and HBV deoxyribonucleic acid (DNA) below the lower limit of quantification (LLOQ)
Measured: 24 Weeks post AHB-137 treatment
Secondary outcomes (26)
Proportion of participants with functional cure (FC) or sustained HBV DNA response off all HBV treatment
Measured: Off-treatment follow-up (Week 48 to 96)
Proportion of participants with functional cure (FC)
Measured: Week 72
Proportion of participants with sustained HBV DNA response
Measured: From baseline through Week 72
Proportion of participants with HBsAg ≤10 IU/mL and HBV DNA < Lower Limit of Quantification (LLOQ) post AHB-137 treatment
Measured: 24 weeks post AHB-137 treatment
Proportion of participants with HBsAg <100 IU/mL and HBV DNA < LLOQ
Measured: 24 weeks post AHB-137 treatment and at Week 72
Proportion of participants with complete response (CR)
Measured: From baseline through end of study (Week 96)
Proportion of participants with HBsAg < or ≥ LOD (0.05 IU/mL) and/or HBV DNA < or ≥ LLOQ
Measured: From baseline through end of study (Week 96)
Proportion of participants with ultrasensitive HBsAg < LOD (0.005 IU/mL)
Measured: From baseline through end of study (Week 96)
Proportion of participants with HBsAg ≤ 10 IU/mL and < 100 IU/mL
Measured: From baseline through end of study (Week 96)
Proportion of participants that meet nucleos(t)ide analog (NA) discontinuation criteria
Measured: Week 48
Categorical change from baseline in serum hepatitis B surface antigen (HBsAg) levels, defined as reductions of ≥0.5, ≥1.0, ≥1.5, ≥2.0, or ≥3.0 log₁₀ IU/mL, assessed at each scheduled study visit
Measured: From baseline through end of study (Week 96), assessed at each scheduled visit
Proportion of participants with anti-HBs seroconversion (with hepatitis B surface antibody [HBsAb] > 10 IU/L)
Measured: Weeks 24, 48, and 72
Quantitative hepatitis B virologic and serologic markers over time
Actual values and change from baseline over time in quantitative hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B virus (HBV) DNA, HBV ribonucleic acid (RNA), hepatitis B core-related antigen (HBcrAg), hepatitis B e antibody (HBeAb), and hepatitis B e antigen (HBeAg), summarized descriptively.
Measured: From baseline through end of study (Week 96)
Proportion of participants who experience virologic relapse
Measured: From baseline through Week 72
Time from nucleos(t)ide analog (NA) therapy discontinuation to virologic relapse
Measured: From NA therapy discontinuation (Week 48) through end of follow-up (Week 96)
Change from baseline in alanine aminotransferase (ALT)
Measured: From baseline through end of study (Week 96)
Proportion of participants with baseline ALT above the upper limit of normal (ULN) who achieve ALT normalization
Measured: From baseline through end of study (Week 96)
Proportion of patients with drug-resistant mutations
Measured: From baseline through end of study (Week 96)
Proportion of participants with treatment-emergent adverse events (TEAEs)
Proportion of participants who experience treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study treatment.
Measured: From first dose (Day 1) through end of study (Week 96)
Proportion of participants with detectable anti-drug antibody (ADA) to AHB-137 and corresponding ADA titers
Measured: From baseline through end of study (Week 96)
Area under the plasma concentration-time curve (AUC) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Concentration at the end of the dosing interval (Ct) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Maximum observed plasma concentration (Cmax) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Time to maximum observed plasma concentration (Tmax) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Apparent plasma clearance (CL/F) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Population Pharmacokinetic and Exposure-Response Analyses of AHB-137
Population pharmacokinetic modeling of AHB-137, including covariate analysis and assessment of exposure-response relationships for pharmacodynamic, efficacy, and safety endpoints.
Measured: From first dose (Day 1) through end of study (Week 96)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start6 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AusperBio Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Audrey Lau, MD, PhD, Study chair, AusperBio Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370207
- Sponsor's protocol ID
- AB-10-8011
- Acronym
- ASPIRE-201
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)Ide Analogue-treated Participants With HBeAg Negative Chronic Hepatitis B in the Asia Pacific Region
- ClinicalTrials.gov ID
- NCT07370207
- Acronym / sponsor ID
- ASPIRE-201 / AB-10-8011
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis, Chronic Hepatitis, Chronic Hepatitis B, Hepatitis B, Hepatitis B, Chronic, Hepatitis B Virus, hepatitis B virus e-antigen, AHB-137
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- AusperBio Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jan 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 a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: AHB-137 + 2 LDs | Experimental | Drug: AHB-137AHB-137 300 mg subcutaneous (SC) weekly for 24 weeks with 2 loading doses (LDs) on Days 4 and 11 |
| Arm B: AHB-137 + 3 LDs | Experimental | Drug: AHB-137AHB-137 300 mg SC weekly for 24 weeks with 3 LDs on Days 4, 11, and 18 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.
- Body mass index (BMI) ≤35 kg/m².
- Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.
- Hepatitis B e antigen (HBeAg) negative at Screening.
Key exclusion criteria (35 listed)
- Clinically significant disease other than chronic hepatitis B virus (HBV) infection, as documented in medical history or identified on physical examination, including but not limited to acute coronary syndrome within 6 months prior to Screening, significant or unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, or prior solid organ or bone marrow transplant
- Concomitant clinically significant liver disease, including but not limited to viral hepatitis caused by other pathogens, hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, drug-induced liver injury, or current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, hepatorenal syndrome, or variceal hemorrhage).
- Any severe infection (other than chronic HBV infection) within 1 month prior to randomization and/or requiring intravenous anti-infective therapy.
- History of immune thrombocytopenia.
- Current suspected liver cirrhosis and/or evidence of cirrhosis defined as liver stiffness measurement (LSM) >9 kPa by FibroScan® or equivalent imaging modality (e.g., ultrasound elastography).
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-137Subcutaneous injection | Drug | Arm A: AHB-137 + 2 LDs, Arm B: AHB-137 + 3 LDs |
Primary outcome
Proportion of participants with sustained response post AHB-137 treatment
Time frame: 24 Weeks post AHB-137 treatment
Sustained response defined as hepatitis B surface antigen (HBsAg) level below the limit of detection (LOD, 0.05 international units [IU]/mL) and HBV deoxyribonucleic acid (DNA) below the lower limit of quantification (LLOQ)
26 secondary outcomes
Proportion of participants with functional cure (FC) or sustained HBV DNA response off all HBV treatment
Time frame: Off-treatment follow-up (Week 48 to 96)
Proportion of participants with functional cure (FC)
Time frame: Week 72
Proportion of participants with sustained HBV DNA response
Time frame: From baseline through Week 72
Proportion of participants with HBsAg ≤10 IU/mL and HBV DNA < Lower Limit of Quantification (LLOQ) post AHB-137 treatment
Time frame: 24 weeks post AHB-137 treatment
Proportion of participants with HBsAg <100 IU/mL and HBV DNA < LLOQ
Time frame: 24 weeks post AHB-137 treatment and at Week 72
Proportion of participants with complete response (CR)
Time frame: From baseline through end of study (Week 96)
Proportion of participants with HBsAg < or ≥ LOD (0.05 IU/mL) and/or HBV DNA < or ≥ LLOQ
Time frame: From baseline through end of study (Week 96)
Proportion of participants with ultrasensitive HBsAg < LOD (0.005 IU/mL)
Time frame: From baseline through end of study (Week 96)
Proportion of participants with HBsAg ≤ 10 IU/mL and < 100 IU/mL
Time frame: From baseline through end of study (Week 96)
Proportion of participants that meet nucleos(t)ide analog (NA) discontinuation criteria
Time frame: Week 48
Categorical change from baseline in serum hepatitis B surface antigen (HBsAg) levels, defined as reductions of ≥0.5, ≥1.0, ≥1.5, ≥2.0, or ≥3.0 log₁₀ IU/mL, assessed at each scheduled study visit
Time frame: From baseline through end of study (Week 96), assessed at each scheduled visit
Proportion of participants with anti-HBs seroconversion (with hepatitis B surface antibody [HBsAb] > 10 IU/L)
Time frame: Weeks 24, 48, and 72
Quantitative hepatitis B virologic and serologic markers over time
Time frame: From baseline through end of study (Week 96)
Proportion of participants who experience virologic relapse
Time frame: From baseline through Week 72
Time from nucleos(t)ide analog (NA) therapy discontinuation to virologic relapse
Time frame: From NA therapy discontinuation (Week 48) through end of follow-up (Week 96)
Change from baseline in alanine aminotransferase (ALT)
Time frame: From baseline through end of study (Week 96)
Proportion of participants with baseline ALT above the upper limit of normal (ULN) who achieve ALT normalization
Time frame: From baseline through end of study (Week 96)
Proportion of patients with drug-resistant mutations
Time frame: From baseline through end of study (Week 96)
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time frame: From first dose (Day 1) through end of study (Week 96)
Proportion of participants with detectable anti-drug antibody (ADA) to AHB-137 and corresponding ADA titers
Time frame: From baseline through end of study (Week 96)
Area under the plasma concentration-time curve (AUC) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Concentration at the end of the dosing interval (Ct) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Maximum observed plasma concentration (Cmax) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Time to maximum observed plasma concentration (Tmax) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Apparent plasma clearance (CL/F) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Population Pharmacokinetic and Exposure-Response Analyses of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 96)
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 13 Oct 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.
Toll Free-North America contact
Audrey Lau, MD, PhD study chair
AusperBio Therapeutics Inc.
10 sites in 7 countries: 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 Hepatitis B, Chronic, run by AusperBio Therapeutics Inc. at 10 sites in 7 countries.
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 12 inclusion and 35 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 13 Oct 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 Taiwan, Japan, Australia, China, New Zealand and 2 more countries. 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 Debbie Liao ((650) 650-2877, ausperbioclinicaltrials@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 sustained response post AHB-137 treatment (time frame: 24 Weeks post AHB-137 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 13 Oct 2026.