Hepatitis B, ChronicPhase 1EXTEND-101NCT07617194
Study of AHB-171 in Chronic Hepatitis B Participants
A Phase 1 study testing AHB-171 and Nucleos(t)ide Analogue (NA) in people with Hepatitis B, Chronic, run by AusperBio Therapeutics Inc. at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety… 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-171 and Nucleos(t)ide Analogue (NA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jul 2026to 14 Aug 2028
- Phase
- Phase 1
- 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
- Male or female participants, aged 18-65 years old (inclusive)
- Body Mass Index between 19 to 35 kg/m2 (inclusive)
- Body weight > or = 45 kg.
- Documented HBV infection for ≥6 months prior to randomization.
- For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
- For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.
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- Screening electrocardiogram (ECG) without clinically significant abnormalities
- Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal).
- Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.
- Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.
Who cannot join
- Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
- Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
- History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
- Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
- HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
- Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.
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- Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).
- Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).
- History or signs of vasculitis or related autoimmune diseases.
- Malignancy within 5 years (except non-melanoma skin cancer).
- Allergy to study drug components.
- Recent major surgery/trauma (within 3 months) or planned surgery during study.
- Alcohol or substance abuse affecting compliance.
- Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.
- Participation in another clinical trial or recent investigational product use.
- Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.
- Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.
- Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped).
- Any other condition making the participant unsuitable (per investigator).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.
- Conditions
- Hepatitis B, Chronic
- Being tested
- AHB-171, Placebo matching [Investigational Product], Nucleos(t)ide Analogue (NA)
- 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-171Drug
Injection
Placebo matching [Investigational Product]Drug
Injection
Nucleos(t)ide Analogue (NA)Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]) | Experimental | Not described Receives: Drug: AHB-171; Drug: Placebo matching [Investigational Product]; Drug: Nucleos(t)ide Analogue (NA) |
| AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD]) | Experimental | Not described Receives: Drug: AHB-171; Drug: Placebo matching [Investigational Product]; Drug: Nucleos(t)ide Analogue (NA) |
| AHB-171 and placebo in CHB (Part C: finite MD) | Experimental | Not described Receives: Drug: AHB-171; Drug: Placebo matching [Investigational Product] |
| AHB-171 and placebo in CHB (Part D: finite MD) | Experimental | Not described Receives: Drug: AHB-171; Drug: Placebo matching [Investigational Product] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Measured: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.
Measured: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171
Measured: Up to 72 weeks
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure
Measured: Up to 72 weeks
Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]
12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval.
Measured: Up to 72 weeks
Incidence of laboratory abnormalities [Safety and Tolerability]
Measured: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171
Measured: Up to 72 weeks
Secondary outcomes (27)
Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
Measured: Up to 72 weeks
Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Proportion of participants achieving HBsAg < or ≥ LOD (limit of detection) and/or HBV DNA < or ≥ LLOQ (lower limit of quantitation) across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study
Measured: Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) levels
Measured: Up to 72 weeks
Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Proportion of participants experiencing virologic relapse.
Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
Measured: Up to 72 weeks
Time to participants experiencing virologic relapse.
Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
Measured: Up to 72 weeks
Proportion of participants with treatment emergent AEs (TEAEs), serious AEs (SAEs), or discontinuation due to AEs.
Measured: Up to 72 weeks
Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
Measured: Up to 72 weeks
ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Plasma PK parameters AUC of AHB-171 and metabolites.
Measured: Up to 72 weeks
Plasma PK parameter Cmax of AHB-171 and metabolites.
Measured: Up to 72 weeks
Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
Measured: Up to 72 weeks
Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
Measured: Up to 72 weeks
Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
Measured: Up to 72 weeks
Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
Measured: Up to 72 weeks
Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study
Measured: Up to 72 weeks
Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study.
Measured: Up to 72 weeks
Absolute serum HBsAb (Hepatitis B surface Antibody) and change from baseline across all evaluated timepoints in the study.
Measured: Time Frame: Up to 72 weeks
Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start6 Jul 2026 (estimated)
- Primary completion8 Oct 2027 (estimated)
- Study completion14 Aug 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AusperBio Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617194
- Sponsor's protocol ID
- AB-17-8001
- Acronym
- EXTEND-101
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 1 Jun 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171
- ClinicalTrials.gov ID
- NCT07617194
- Acronym / sponsor ID
- EXTEND-101 / AB-17-8001
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- AusperBio Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (estimated)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 1 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 goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]) | Experimental | Drug: AHB-171, Drug: Placebo matching [Investigational Product], Drug: Nucleos(t)ide Analogue (NA) |
| AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD]) | Experimental | Drug: AHB-171, Drug: Placebo matching [Investigational Product], Drug: Nucleos(t)ide Analogue (NA) |
| AHB-171 and placebo in CHB (Part C: finite MD) | Experimental | Drug: AHB-171, Drug: Placebo matching [Investigational Product] |
| AHB-171 and placebo in CHB (Part D: finite MD) | Experimental | Drug: AHB-171, Drug: Placebo matching [Investigational Product] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants, aged 18-65 years old (inclusive)
- Body Mass Index between 19 to 35 kg/m2 (inclusive)
- Body weight > or = 45 kg.
- Documented HBV infection for ≥6 months prior to randomization.
- For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
Key exclusion criteria (19 listed)
- Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
- Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
- History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
- Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
- HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
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-171Injection | Drug | AHB-171 and placebo in CHB (Part C: finite MD), AHB-171 and placebo in CHB (Part D: finite MD), AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]), AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD]) |
| Placebo matching [Investigational Product]Injection | Drug | AHB-171 and placebo in CHB (Part C: finite MD), AHB-171 and placebo in CHB (Part D: finite MD), AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]), AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD]) |
| Nucleos(t)ide Analogue (NA)Oral administration | Drug | AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD]), AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD]) |
Primary outcome
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Time frame: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.
Time frame: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171
Time frame: Up to 72 weeks
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Time frame: Up to 72 weeks
Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure
Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]
Time frame: Up to 72 weeks
12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval.
Incidence of laboratory abnormalities [Safety and Tolerability]
Time frame: Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171
Time frame: Up to 72 weeks
27 secondary outcomes
Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
Time frame: Up to 72 weeks
Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Proportion of participants achieving HBsAg < or ≥ LOD (limit of detection) and/or HBV DNA < or ≥ LLOQ (lower limit of quantitation) across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study
Time frame: Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) levels
Time frame: Up to 72 weeks
Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Proportion of participants experiencing virologic relapse.
Time frame: Up to 72 weeks
Time to participants experiencing virologic relapse.
Time frame: Up to 72 weeks
Proportion of participants with treatment emergent AEs (TEAEs), serious AEs (SAEs), or discontinuation due to AEs.
Time frame: Up to 72 weeks
Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
Time frame: Up to 72 weeks
ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Plasma PK parameters AUC of AHB-171 and metabolites.
Time frame: Up to 72 weeks
Plasma PK parameter Cmax of AHB-171 and metabolites.
Time frame: Up to 72 weeks
Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
Time frame: Up to 72 weeks
Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
Time frame: Up to 72 weeks
Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
Time frame: Up to 72 weeks
Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
Time frame: Up to 72 weeks
Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study
Time frame: Up to 72 weeks
Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study.
Time frame: Up to 72 weeks
Absolute serum HBsAb (Hepatitis B surface Antibody) and change from baseline across all evaluated timepoints in the study.
Time frame: Time Frame: Up to 72 weeks
Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
Time frame: Up to 72 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 1 Jun 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AHB-171 and Nucleos(t)ide Analogue (NA) in people with Hepatitis B, Chronic, run by AusperBio Therapeutics Inc. at 2 sites in 2 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 10 inclusion and 19 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong, New Zealand. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Adverse Events (AEs) [Safety and Tolerability] (time frame: Up to 72 weeks). The study lists 7 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 1 Jun 2026.