AHB-137 Injection for Chronic Hepatitis B

Recruiting at 8 trial locations

Overseen By Chen Yang

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ausper Biopharma Co., Ltd.

Must be taking: HBV OAV treatments

Disqualifiers: Cirrhosis, Liver disease, Co-infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new injection called AHB-137 for individuals with chronic hepatitis B (CHB). Researchers aim to evaluate the drug's efficacy and how the body processes it in both healthy volunteers and patients with CHB. The trial includes several groups: some will receive single doses, while others will receive multiple doses to assess any antiviral effects. Individuals with CHB who have had the infection for at least six months, with no recent changes in their medications, might be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are a CHB patient participating in Part D, you must have been on your current HBV treatment for at least 6 months without changes for 3 months before the trial.

Is there any evidence suggesting that AHB-137 is likely to be safe for humans?

Research has shown that AHB-137 has been tested for safety and effectiveness in earlier studies. In one study on chronic hepatitis B, AHB-137 proved to be safe and effective, indicating that it is generally well-tolerated. However, the current trial, being in an early stage, primarily focuses on assessing the treatment's safety and tolerability. Participants should understand that this step is crucial to ensure the treatment's safety for a broader population in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AHB-137 for chronic hepatitis B because it offers a fresh approach with its unique mechanism of action. Unlike current standard treatments, such as nucleos(t)ide analogs and interferons, which primarily focus on suppressing the virus, AHB-137 is designed to target and disrupt the virus at a genetic level. This could potentially lead to a more effective clearance of the virus. Additionally, AHB-137 is administered via subcutaneous injection, which may offer a more convenient and less invasive option compared to traditional treatments. This innovation could pave the way for more efficient management of chronic hepatitis B.

What evidence suggests that AHB-137 might be an effective treatment for chronic hepatitis B?

Research shows that AHB-137, which participants in this trial may receive, could help treat chronic hepatitis B (CHB). In earlier studies, AHB-137 proved to be safe and effective, particularly in a Phase 2b trial where it demonstrated antiviral effects. AHB-137 is a new treatment that targets the virus's genetic material to reduce the virus in the body. Some studies suggest it might increase the chances of a functional cure, meaning it could lower the virus to undetectable levels. These findings offer hope for CHB patients seeking new treatment options. ^{1 2 4 6 7}

Who Is on the Research Team?

Ed Gane

Principal Investigator

University of Auckland, New Zealand

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with chronic hepatitis B or healthy individuals meeting specific criteria, including a BMI of 19-35 kg/m2 and weight over 45 kg. Participants must test negative for COVID-19 and agree to study requirements. CHB patients should have stable liver function tests and documented HBV infection for at least six months.

Inclusion Criteria

I am 18-65 years old, have a BMI of 19-35, weigh over 45 kg, and tested negative for COVID-19.

Exclusion Criteria

Healthy participants: Pregnant or lactating women, history or symptoms of clinically significant diseases, history of long QT syndrome, allergic reactions to drugs, abnormal ECG, creatinine clearance ≤ 60 ml/min, positive tests for hepatitis A, B, C, HIV, or TP, abnormal laboratory test results, bleeding diathesis.

I have CHB without other liver diseases, infections, or severe health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part A (SAD in healthy participants)

Single ascending doses of up to 450 mg AHB-137 by subcutaneous injection in healthy participants

4 weeks

Treatment - Part B (MD in healthy participants)

Multiple doses of 300 mg AHB-137 by subcutaneous injection in healthy participants

8 weeks

Treatment - Part C (MD in CHB patients, open label)

Multiple doses of 300 mg AHB-137 by subcutaneous injection in CHB patients

8 weeks

Treatment - Part D (MD in CHB patients, double-blind)

Multiple doses of 200 mg or 300 mg AHB-137 by subcutaneous injection in CHB patients across multiple centers

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AHB-137
• Placebo

Trial Overview AHB-137, a new drug given by injection, is being tested in this study to assess its safety, how the body processes it (pharmacokinetics), tolerability, and initial effectiveness against chronic hepatitis B virus after single or multiple doses compared to a placebo.

How Is the Trial Designed?

Group I: Part D: MD in CHB patients in multiple centers Experimental Treatment 2 Interventions

Part D: Multiple doses of 200 mg or 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients (Multiple centers across multiple regions).

Group II: Part C: MD in CHB patients (open label) Experimental Treatment 1 Intervention

Part C: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in CHB patients.

Group III: Part B: MD in healthy participants Experimental Treatment 2 Interventions

Part B: Multiple doses of 300 mg AHB-137 by subcutaneous (SC) injection in healthy participants.

Group IV: Part A: SAD in healthy participants Experimental Treatment 2 Interventions

Part A: Single ascending doses of up to 450 mg AHB-137 by subcutaneous (SC) injection in healthy participants.

Who Is Running the Clinical Trial?

Ausper Biopharma Co., Ltd.

Lead Sponsor

Trials

4

Recruited

450+

AusperBio Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07137910

A Study to Evaluate the Efficacy and Safety of AHB-137 ... A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). ClinicalTrials.gov ID NCT07137910. Sponsor ...

2. liverdiseasenews.com liverdiseasenews.com/news/ahb-137-effective-chronic-hepatitis-b-phase-2b-clinical-trial/

AHB-137 effective for chronic hepatitis B: Phase 2b clinical ... The investigational therapy AHB-137 was found to be safe and effective in a Phase 2b clinical trial for chronic hepatitis B.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/ausperbio-enrolment-phaseii-hepatitis-rials/

AusperBio completes enrolment in Phase II chronic ... “The AB-10-8007 study aims to combine AHB-137 with approved HBV treatments to further increase functional cure rates, while the AB-10-8008 study ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12038417/

Drug development for chronic hepatitis B functional cure Lenvervimab has demonstrated modest efficacy in clearing HBsAg. In clinical trials, a 12.5% HBsAg clearance rate was observed in the 80000 IU ...

5. prnewswire.com prnewswire.com/news-releases/ausperbio-receives-china-cde-clearance-to-advance-ahb-137-into-phase-iii-clinical-trial-for-chronic-hepatitis-b-302509921.html

AusperBio Receives China CDE Clearance to Advance ... AHB-137 is a novel antisense oligonucleotide under development as a potential functional cure for chronic hepatitis B (CHB). In July 2024, it ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06829329

Study to Evaluate the Efficacy and Safety of AHB-137 in ... The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and ...

7. trialx.com trialx.com/clinical-trials/listings/300238/a-multicenter-study-of-ahb-137-injection-combined-with-other-hepatitis-b-drugs/

A Multicenter Study of AHB-137 Injection Combined With ... This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B ...