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Hepatitis B, ChronicPhase 1/2NCT06115993

A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients

A Phase 1/2 study testing AHB-137 injection in people with Hepatitis B, Chronic, run by Ausper Biopharma Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137 in CHB participants after up to 24 weeks of treatment as a proof-of-concept. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Chronic
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
129 participants
Where
3 sitesChina
Study dates
3 Aug 2023to 10 Nov 2025
Phase
Phase 1/2
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 (Part Ia):
  • The participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening;
  • The participants are able to comply with all the protocol requirements;
  • The participants (and partners) are willing to take effective contraceptive measures from the screening until at least 6 months after the last dosing;
  • Male or female aged 18-55 when signing ICF;
  • Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 50 kg for male and 45 kg for female;
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  • Vital signs and physical examination are normal, or abnormal values are not clinically significant.
  • CHB participants are required to meet all the following inclusion criteria in order to be enrolled in the study (Part Ib and part IIa):
  • The participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening;
  • The participants are able to comply with all the protocol requirements;
  • The participants (and partners) are willing to take effective contraceptive measures from the screening until at least 6 months after the last dosing;
  • Male or female aged 18-65 when signing ICF;
  • Body Mass Index (BMI) between 18 to 32 kg/m2 (inclusive) and body weight equal to or over 45 kg for male and 40 kg for female;
  • participants who have documented chronic HBV infection equal to or above 6 months prior to screening.
  • Stable treatment of HBeAg negative CHB participants;
  • Currently receiving single-agent treatment with stable NAs (TDF, TAF, or ETV) for at least 6 months and no changes in the NAs treatment regimen are planned during the trial;
  • Serum ALT≤2×ULN, HBV DNA < 100 IU/mL. Dose increasing stage of Ib: 100 IU/mL <HBsAg≤1000 IU/mL; Dose expansion stage of Ib: 1000 IU/ml < HBsAg≤3000 IU/mL at screening; IIa phase: 100 IU/ml < HBsAg≤ 3000 IU/mL at screening;
  • Participants who are willing and able to terminate NA treatment according to the protocol in IIa stage.

Who cannot join

  • Healthy participants are required to not meet any of the exclusion criteria in order to be enrolled in the study (Part Ia):
  • Any suspicat screening ion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
  • Blood donation or blood loss not less than 400 mL within 12 weeks before screening;
  • Drug administration that change the activity of liver enzymes within 28 days prior to screening;
  • Receipt of another investigational drug or device within 3 months before first dosing (interventional treatment);
  • Clinically significant electrocardiogram (ECG) abnormalities on screening ECG;
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  • TdP high-risk factors (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and QTc interval above 450 msec in participants (judged by investigator based on actual screening conditions);
  • Pregnant (positive pregnancy test), recently ready to conceive, or lactating female;
  • Clinically significant lab examination abnormalities, or other clinically significant diseases discovered within 12 months before screening, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases;
  • Any acute disease or concomitant medication occurred during screening to the first dosing;
  • Alcohol consumption, or positive alcohol test 24 hours before drug dosing;
  • Positive test for urinalysis (including Morphine, Cannabis) in participants;
  • Other factors resulting in participant becoming unsuitable for the study, determined by the investigator.
  • CHB participants are required to not meet any of the exclusion criteria in order to be enrolled in the study (Part Ib and Part IIa):
  • Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
  • Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
  • Any oligonucleotide or siRNA treatments within 12 months before first dosing;
  • Any immunosuppressing, immunomodulator (e.g. Thymosin) or cytotoxic drug administrations within 6 months before first dosing; Vaccination within 1 month in prior of screening, or plan to take any vaccines during the study;
  • Receiving anticoagulant therapy for Ib phase (e.g., Warfarin, Factor Xa Inhibitors or antiplatelet drugs such as Clopidogrel);
  • Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.;
  • Personal history of cirrhosis or progressive hepatic fibrosis (e.g., the participant undergoes hepatic histopathological examination, which indicates cirrhosis, or undergoes endoscopic examination indicating esophagogastric varices);
  • Confirmation or suspicion of decompensated hepatitis B cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, esophageal and gastric variceal bleeding, ascites, primary hepatocellular carcinoma, etc.;
  • History of malignancy within the past 5 years, except for certain tumors that can be cured by surgical resection (e.g., non-melanoma skin cancer, cervical intraepithelial neoplasia, thyroid neoplasm, breast tumor, etc. that have been treated without signs of recurrence);
  • Combined sever diseases of circulation, digestion, respiration, urinary, blood, metabolism, immune, nervous system, etc.;
  • Participants for IIa phase with high-risk factors for TdP (hypokalemia, hypomagnesemia, decompensated heart failure, and acute myocardial infarction), baseline QTc interval longer than 450 ms (determined by the researchers based on actual screening);
  • Acute infection within 2 weeks prior to screening;
  • Receipt of another investigational drug or device within 1 month before screening (interventional treatment);
  • Laboratorial examination: blood platelet counts<90 x 10^9/L, absolute neutrophil count<1.3 x 10^9/L, hemoglobin<90 g/L, serum total bilirubin ≥2 x ULN, albumin<30 g/L, creatinine clearance rate (calculated by MDRD formula) ≤60 mL/min, PT/INR>1.5;
  • Alpha-fetoprotein (AFP) >70 ug/L, or imaging suspicion of malignant hepatic space-occupying;
  • HCV antibody/HCcAg positive, AIDS antigen/antibody positive, or Treponema Pallidum antibody positive and Rapid Plasma Reagin (RPR) or Toluidine Red Unheated Serum Test (TRUST) positive, or Hepatitis D antibody positive;
  • LSM≥12.4 kPa when screening;
  • Pregnant (positive pregnancy test) or lactating female;
  • Positive test for urinalysis (including Morphine, Cannabis) or alcohol test in participants;
  • Other factors results in unsuitable for the study, determined by the investigator.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Nanfang Hospital, Southern Medical University

    Guangzhou

  • The First Hospital of Jilin University

    Jilin City

Other trials in China

About this study

Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Single Ascending Doses and Multiple Doses of AHB-137 in Healthy Participants and HBeAg-negative CHB Patients Receiving Stable Nucleos(t)Ide Analogues (NAs) Treatment

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137 in CHB participants after up to 24 weeks of treatment as a proof-of-concept.

Read the detailed description

This study is a three-part study of AHB-137, including Part Ia, Part Ib and Part IIa. Part Ia evaluates the safety, tolerability, pharmacokinetics of AHB-137 following single-ascending doses (SAD) and multiple-ascending doses (MAD) in healthy participants. Part Ib is a multiple-dose study to assess the safety, tolerability, pharmacokinetics, and initial efficacy of AHB-137 in CHB participants following weekly dosing for 4 weeks with two loading doses in the first two weeks. Part IIa is a multiple-dose study to evaluate the preliminary efficacy, safety and pharmacokinetics of AHB-137 in CHB participants following weekly dosing for 24 weeks with two loading doses in the first two weeks.

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 injection will be administered subcutaneously.

  • PlaceboDrug

    Placebo will be administered subcutaneously.

Study groups in NCT06115993
Study groupRoleWhat they receive
Part Ia: dosing in healthy participantsExperimentalSAD of 75 mg, 150 mg, 300 mg and 450 mg AHB-137 and MAD of 150 mg and 300 mg AHB-137 by subcutaneous injections within a month in healthy participants.
Receives: Drug: AHB-137 injection; Drug: Placebo
Part Ib: dosing in CHB participantsExperimentalDose escalation cohort: MAD of 150 mg and 300 mg AHB-137 by subcutaneous injections within a month in CHB participants who are under stable NAs therapy. Dose expansion cohort: Multiple doses of 300 mg AHB-137 by subcutaneous injections within a month in CHB participants who are under stable NAs therapy.
Receives: Drug: AHB-137 injection; Drug: Placebo
Part IIa: proof of conceptExperimentalMultiple doses of 225 mg or 300 mg AHB-137 by subcutaneous injections within 24 weeks in CHB participants who are under stable NAs therapy.
Receives: Drug: AHB-137 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of healthy participants with TEAEs, SAEs

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  2. Number of healthy participants with clinically significant changes in laboratory parameters

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  3. Number of healthy participants with clinically significant changes in vital signs

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  4. Number of healthy participants with clinically significant changes in ECG

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  5. Number of healthy participants with ADA

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  6. The pharmacokinetic profile of AHB-137 in healthy participants: the Cmax of AHB-137

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  7. The pharmacokinetic profile of AHB-137 in healthy participants: Tmax of AHB-137

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  8. The pharmacokinetic profile of AHB-137 in healthy participants: AUC of AHB-137

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  9. The pharmacokinetic profile of AHB-137 in healthy participants: t1/2 of AHB-137

    Measured: Up to 30 days for SAD; up to 113 days for MAD

  10. Number of CHB participants with TEAEs, SAEs

    Measured: Up to 113 days for Ib

  11. Number of CHB participants with clinically significant changes in laboratory parameters

    Measured: Up to 113 days for Ib

  12. Number of CHB participants with clinically significant changes in vital signs

    Measured: Up to 113 days for Ib

  13. Number of CHB participants with clinically significant changes in ECG

    Measured: Up to 113 days for Ib

  14. Proportion of participants achieving HBsAg lower than LLOQ (0.05 IU/mL) and HBV DNA lower than LLOQ at the end of treatment with AHB-137, regardless of whether HBsAg seroconversion is observed

    Measured: At week 24 for IIa

Secondary outcomes (12)

  1. The anti-HBV efficacy of AHB-137 in CHB participants: evaluate the serum levels of HBV DNA, HBsAg, HBV RNA, HBsAb, HBeAb

    Measured: Up to 113 days for Ib; Up to 72 weeks for IIa

  2. Evaluate the serum levels of sensitive HBsAg (LLOQ ≤0.005 IU/mL) and HBcrAg.

    Measured: Up to 72 weeks for IIa

  3. The pharmacokinetic profile of AHB-137 in CHB participants: the Cmax of AHB-137

    Measured: up to 113 days for Ib; Up to 48 weeks for IIa

  4. The pharmacokinetic profile of AHB-137 in CHB participants: Tmax of AHB-137

    Measured: up to 113 days for Ib; Up to 48 weeks for IIa

  5. The pharmacokinetic profile of AHB-137 in CHB participants: AUC of AHB-137

    Measured: up to 113 days for Ib; Up to 48 weeks for IIa

  6. The pharmacokinetic profile of AHB-137 in CHB participants: t1/2 of AHB-137

    Measured: up to 113 days for Ib; Up to 48 weeks for IIa

  7. Number of CHB participants with ADA

    Measured: Up to113 days for Ib; Up to 48 weeks for IIa

  8. Number of CHB participants with TEAEs, SAEs

    Measured: Up to 72 weeks for IIa

  9. Number of CHB participants with clinically significant changes in laboratory parameters, ECG, and vital signs

    Measured: Up to 72 weeks for IIa

  10. Proportion of CHB participants achieving HBsAg lower than LLOQ and HBV DNA lower than LLOQ during or after 24-week treatment, regardless of whether HBsAg seroconversion is observed

    Measured: Up to 72 weeks for IIa

  11. Proportion of CHB participants meeting the discontinuation criteria for NA treatment

    Measured: At 48 weeks for IIa

  12. Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137

    Measured: Up to 113 days for Ib; Up to 72 weeks for IIa

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start3 Aug 2023
  3. Primary completion3 Dec 2024
  4. Study completion10 Nov 2025

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115993
Sponsor's protocol ID
AB-10-8002
Status last verified
May 2026
First submitted
11 Oct 2023
Last updated
7 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang W, Mai J, Hou J, Xu Z, Yu X, Ren H, Liang X, Yang Y, Liu Z, Zhang H, Zhong S, Wen Y, Lu T, Cao H, Qiu X, Wang L, Zhao D, Wang M, Yang C, Cheng G, Niu J, Ding Y. Safety, pharmacokinetics and antiviral activity of AHB-137 in healthy volunteers and chronic hepatitis B patients: a phase 1a/1b study. Hepatol Int. 2026 May 23. doi: 10.1007/s12072-026-11102-7. Online ahead of print.

    PubMed 42176239

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AHB-137 injection in people with Hepatitis B, Chronic, run by Ausper Biopharma Co., Ltd. at 3 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 18 inclusion and 34 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 combined 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.

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?

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?

Number of healthy participants with TEAEs, SAEs (time frame: Up to 30 days for SAD; up to 113 days for MAD). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06115993, which also lists 1 linked publication.

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 7 May 2026.

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