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

Trial Summary

What is the purpose of this trial?

This trial tests a new injection called AHB-137 in healthy people and those with chronic hepatitis B. It aims to see if the medicine is safe, how the body processes it, and its initial effects on the virus.

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.

Research Team

Ed Gane

Principal Investigator

University of Auckland, New Zealand

Eligibility Criteria

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

CHB patients: Written informed consent, age 18 to 65 years old, ALT ≤ 5 ULN for Part C or ≤ 2 ULN for Part D, chronic HBV infection ≥ 6 months prior to screening or HBsAg positive and IgM HBcAb negative, on HBV OAV treatment for at least 6 months with no regimen change for 3 months prior to screening, HBV DNA under LOQ at Screening, both HBeAg positive and negative CHB patients for Part C, only HBeAg negative CHB patients for Part D, negative COVID-19 RAT test at check-in.

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

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

Treatment Details

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.

Participant Groups

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+