Chronic Hepatitis BPhase 1NCT05717686
A Study Evaluating AHB-137 in Healthy Participants and Participants with Chronic Hepatitis B
A Phase 1 study testing AHB-137 injection in people with Chronic Hepatitis B, run by AusperBio Therapeutics Inc. at 9 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- AHB-137 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 28 Feb 2023to 7 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants are required to meet all the following inclusion criteria in order to be enrolled in the study:
- 18-65 years old male or female.
- Body Mass Index (BMI) between 19 to 35 kg/m2 (inclusive) and body weight equal to or over 45 kg.
- Participants' COVID-19 PCR test should be negative during screening.
- Participants' COVID-19 Rapid Antigen Test (RAT) should be negative at check-in.
- CHB patients are required to meet all the following inclusion criteria in order to be enrolled in the study:
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- Have given written informed consent (signed and dated) and any authorizations required by local law and is able to comply with all study requirements.
- Age 18 to 65 years old.
- ALT ≤ 5 ULN for CHB patients recruited to Part C; ALT ≤ 2 ULN for CHB patients recruited to Part D.
- CHB patients who have documented chronic HBV infection equal to or above 6 months prior to screening. Otherwise, CHB patients need to be HBsAg positive and IgM HBcAb negative.
- CHB patients participating in Part D should have been on commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening. HBV DNA under limit of quantification (LOQ) at Screening.
- Both HBeAg positive and negative CHB patients can be recruited to Part C of the study. Only HBeAg negative CHB patients can be recruited to Part D of the study.
- COVID-19 RAT test should be negative at check-in.
Who cannot join
- Healthy participants are required to not meet any of the following exclusion criteria in order to be enrolled in the study:
- Pregnant (positive pregnancy test) or lactating women. Male participants without using proper contraceptives (e.g. condom) with partners who are pregnant or lactating.
- History or symptoms of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- Personal history of congenital long QT syndrome or family history of sudden cardiac death.
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- Any clinically significant concomitant diseases or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.
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- Clinically relevant electrocardiogram (ECG) abnormalities on screening ECG.
- ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement.
- Creatinine clearance (CrCl) cutoff ≤ 60 ml/min (using the Cockcroft-Gault formula).
- Positive test at screening of any of the following: hepatitis A (HAV IgM Ab), hepatitis B (HBsAg), hepatitis C (HCV RNA or HCV Ab), human immunodeficiency virus 1 and 2 (HIV Ab), or TP-Ab.
- Any other clinically significant abnormalities in laboratory test results at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility.
- History of bleeding diathesis or coagulopathy.
- CHB patients are required to not meet any of the following exclusion criteria in order to be enrolled in the study:
- History of liver cirrhosis and/or evidence of cirrhosis as determined by any 1 of the following:
- Liver biopsy (i.e., Metavir Score F4) within 2 years of screening, or
- FibroScan > 12 KPa, within 12 months of screening, or
- AST-to-Platelet Index (APRI) > 2 and FibroSure result > 0.7 within 12 months of screening.
- For patients without a test for cirrhosis in the above timeframes, FibroScan, or APRI and FibroSure, may be performed during the screening period to rule out cirrhosis History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices.
- History of liver disease other than hepatitis B.
- Co-infection with TP, HCV, HIV, or hepatitis D virus (HDV).
- Body mass index >35 kg/m2 .
- History or suspected presence of vasculitis .
- Diagnosed hepatocellular carcinoma or suspected hepatocellular carcinoma as evidenced by screening alpha-fetoprotein ≥200 ng/mL. If the screening alpha-fetoprotein is ≥50 ng/mL and <200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization.
- Clinically relevant electrocardiogram (ECG) abnormalities on screening ECG.
- Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a patient unsuitable for inclusion.
- ALT > 5 x ULN for Part C or > 2 x ULN for Part D
- Total bilirubin > 1.25 x ULN
- Serum albumin < 3.4 g/dL
- International normalized ratio of prothrombin time > 1.25
- Platelet count <140 x 10^9/L
- Hemoglobin <12.0 g/dL for males and <11.0 g/dL for females
- White blood cell count <3.0 k/mm3
- Serum creatinine >1.1 x ULN
- Urine protein/creatinine ratio ≥0.2 mg/mg. In the event of a ratio above this threshold, eligibility may be confirmed by a quantitative total urine protein measurement of <150 mg/24 hour
- Positive test (including trace) for blood on urinalysis. In the event of a positive test, eligibility may be confirmed with urine microscopy showing <5 red blood cells per high power field
- Clinically significant abnormalities and/or poorly controlled medical conditions (e.g. Cardiovascular, pulmonary, metabolic disease) in the opinion of the investigator.
- History of bleeding diathesis or coagulopathy.
- History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa) .
- Active infection other than HBV, requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States4 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
American Research Corporation
Houston, Texas, 78215
NYU Langone Health
New York, New York, 10016
Stanford Medicine
Redwood City, California, 94063
Taiwan3 sites
Chia-Yi Christian Hospital
Chiayi City, 60002
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 80756
E-DA Hospital
Kaohsiung, Taiwan, 82445
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AHB-137 with Single Ascending Doses and Multiple Doses in Healthy Volunteers and Initial Efficacy in Chronic Hepatitis B Patients
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of AHB-137 in CHB patients following a multiple dosing regimen.
Read the detailed description
This is a first-in-human study of AHB-137, consisting of four parts. Parts A and B are randomized, double-blinded, placebo-controlled studies designed to assess the safety, tolerability, pharmacokinetics of AHB-137 following subcutaneous injection in healthy volunteers at a 6:2 ratio of AHB-137 to placebo. Part A is a single-ascending dose (SAD) study, and Part B is a single-ascending dose (SAD) study, and Part B is a multiple dose (MD) study. Part C is an open label MD study with up to 6 CHB patients. Part D is a double blinded study in CHB patients at a 4:1 ratio to receive AHB-137 or placebo.
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
- Chronic Hepatitis B
- Being tested
- AHB-137 injection, Placebo
- 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-137 injectionDrug
AHB-137 will be administered
PlaceboDrug
Placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD in healthy participants | Experimental | Part A: Single ascending doses of up to 450 mg AHB-137 by subcutaneous (SC) injection in healthy participants. Receives: Drug: AHB-137 injection; Drug: Placebo |
| Part B: MD in healthy participants | Experimental | Part B: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in healthy participants. Receives: Drug: AHB-137 injection; Drug: Placebo |
| Part C: MD in CHB patients (open label) | Experimental | Part C: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients. Receives: Drug: AHB-137 injection |
| Part D: MD in CHB patients in multiple centers | Experimental | Part D: Multiple doses of 200 mg or 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients (Multiple centers across multiple regions). Receives: Drug: AHB-137 injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in Healthy Volunteers
Measured: Up to 30 days for SAD, up to 113 days for MD
Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in CHB patients
Measured: Up to 204 days for MD
Secondary outcomes (10)
The anti-HBV efficacy of AHB-137: evaluate the change in serum HBsAg (log10 IU/mL) from baseline.
Measured: Up to 204 days
The anti-HBV efficacy of AHB-137: evaluate the expression of HBsAb in serum.
Measured: Up to 204 days
The pharmacokinetic profile of AHB-137: the maximum observed plasma concentration (Cmax) of AHB-137
Measured: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: time of observed maximal concentration (Tmax) of AHB-137
Measured: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: areas under the concentration time curve (AUC) of AHB-137
Measured: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: mean residence time (MRT) of AHB-137
Measured: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: terminal half-life (t1/2) of AHB-137
Measured: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: apparent subcutaneous plasma clearance (CL/F) of AHB-137
Measured: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: amount of AHB-137 excreted in urine (Ae)
Measured: Day 1-4 for SAD; Day 1-4 and Day 22-25 for MD
The pharmacokinetic profile of AHB-137: renal clearance (CLr) of AHB-137
Measured: Day 1-4 for SAD; Day 1-4 and Day 22-25 for MD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start28 Feb 2023
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AusperBio Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ed Gane, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717686
- Sponsor's protocol ID
- AB-10-8001
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AHB-137 with Single Ascending Doses and Multiple Doses in Healthy Volunteers and Initial Efficacy in Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT05717686
- Acronym / sponsor ID
- AB-10-8001
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AusperBio Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 8 Feb 2023 (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 purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of AHB-137 in CHB patients following a multiple dosing regimen.
Detailed description
This is a first-in-human study of AHB-137, consisting of four parts. Parts A and B are randomized, double-blinded, placebo-controlled studies designed to assess the safety, tolerability, pharmacokinetics of AHB-137 following subcutaneous injection in healthy volunteers at a 6:2 ratio of AHB-137 to placebo. Part A is a single-ascending dose (SAD) study, and Part B is a single-ascending dose (SAD) study, and Part B is a multiple dose (MD) study. Part C is an open label MD study with up to 6 CHB patients. Part D is a double blinded study in CHB patients at a 4:1 ratio to receive AHB-137 or placebo.
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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD in healthy participants | Experimental | Drug: AHB-137 injection, Drug: PlaceboPart A: Single ascending doses of up to 450 mg AHB-137 by subcutaneous (SC) injection in healthy participants. |
| Part B: MD in healthy participants | Experimental | Drug: AHB-137 injection, Drug: PlaceboPart B: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in healthy participants. |
| Part C: MD in CHB patients (open label) | Experimental | Drug: AHB-137 injectionPart C: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients. |
| Part D: MD in CHB patients in multiple centers | Experimental | Drug: AHB-137 injection, Drug: PlaceboPart D: Multiple doses of 200 mg or 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients (Multiple centers across multiple regions). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy participants are required to meet all the following inclusion criteria in order to be enrolled in the study:
- CHB patients are required to meet all the following inclusion criteria in order to be enrolled in the study:
Key exclusion criteria (39 listed)
- Healthy participants are required to not meet any of the following exclusion criteria in order to be enrolled in the study:
- CHB patients are required to not meet any of the following exclusion criteria in order to be enrolled in the study:
- History of liver cirrhosis and/or evidence of cirrhosis as determined by any 1 of the following:
- For patients without a test for cirrhosis in the above timeframes, FibroScan, or APRI and FibroSure, may be performed during the screening period to rule out cirrhosis History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices.
- History of liver disease other than hepatitis B.
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-137 injectionAHB-137 will be administered | Drug | Part A: SAD in healthy participants, Part B: MD in healthy participants, Part C: MD in CHB patients (open label), Part D: MD in CHB patients in multiple centers |
| PlaceboPlacebo will be administered | Drug | Part A: SAD in healthy participants, Part B: MD in healthy participants, Part D: MD in CHB patients in multiple centers |
Primary outcome
Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in Healthy Volunteers
Time frame: Up to 30 days for SAD, up to 113 days for MD
Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in CHB patients
Time frame: Up to 204 days for MD
10 secondary outcomes
The anti-HBV efficacy of AHB-137: evaluate the change in serum HBsAg (log10 IU/mL) from baseline.
Time frame: Up to 204 days
The anti-HBV efficacy of AHB-137: evaluate the expression of HBsAb in serum.
Time frame: Up to 204 days
The pharmacokinetic profile of AHB-137: the maximum observed plasma concentration (Cmax) of AHB-137
Time frame: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: time of observed maximal concentration (Tmax) of AHB-137
Time frame: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: areas under the concentration time curve (AUC) of AHB-137
Time frame: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: mean residence time (MRT) of AHB-137
Time frame: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: terminal half-life (t1/2) of AHB-137
Time frame: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: apparent subcutaneous plasma clearance (CL/F) of AHB-137
Time frame: Up to 30 days for SAD; up to 204 days for MD
The pharmacokinetic profile of AHB-137: amount of AHB-137 excreted in urine (Ae)
Time frame: Day 1-4 for SAD; Day 1-4 and Day 22-25 for MD
The pharmacokinetic profile of AHB-137: renal clearance (CLr) of AHB-137
Time frame: Day 1-4 for SAD; Day 1-4 and Day 22-25 for MD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- 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.
Ed Gane principal investigator
University of Auckland, New Zealand
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AHB-137 injection in people with Chronic Hepatitis B, run by AusperBio Therapeutics Inc. at 9 sites in 4 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 13 inclusion and 39 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: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Taiwan, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Treatment-Emergent Adverse Events (TEAEs) in Healthy Volunteers (time frame: Up to 30 days for SAD, up to 113 days for MD). The study lists 2 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 14 Feb 2025.