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Antiviral

AHB-137 Injection for Chronic Hepatitis B

Phase 1

Waitlist Available

Led By Ed Gane

Research Sponsored by Ausper Biopharma Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1-4 for sad; day 1-4 and day 22-25 for md

Awards & highlights

Study Summary

This trial will assess the safety, effectiveness, and how the body processes a subcutaneous injection of AHB-137 for healthy volunteers and chronic hepatitis B patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not detailed here but typically include reactions at the injection site, general discomforts like headaches or fatigue, possible allergic reactions, and any organ-specific issues that may arise from the medication's action on the virus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1-4 for sad; day 1-4 and day 22-25 for md

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1-4 for sad; day 1-4 and day 22-25 for md

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-4 for sad; day 1-4 and day 22-25 for md for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in CHB patients

Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) in Healthy Volunteers

Secondary outcome measures

The anti-HBV efficacy of AHB-137: evaluate the change in serum HBsAg (log10 IU/mL) from baseline.

The anti-HBV efficacy of AHB-137: evaluate the expression of HBsAb in serum.

The pharmacokinetic profile of AHB-137: amount of AHB-137 excreted in urine (Ae)

+7 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D: MD in CHB patients in multiple centersExperimental Treatment2 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 Treatment1 Intervention

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

Group III: Part B: MD in healthy participantsExperimental Treatment2 Interventions

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

Group IV: Part A: SAD in healthy participantsExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ausper Biopharma Co., Ltd.Lead Sponsor

1 Previous Clinical Trials

270 Total Patients Enrolled

AusperBio Therapeutics Inc.Lead Sponsor

Ed GanePrincipal InvestigatorUniversity of Auckland, New Zealand

1 Previous Clinical Trials

31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial allow minors to participate?

"The age criteria to participate in this study is between 18 and 65 years old."

Answered by AI

Are any new participants currently being enrolled in this trial?

"Affirmative. Clinicaltrials.gov shows that recruitment began on February 28th 2023 and was recently updated October 5th, with 90 participants needed from 2 locations."

Answered by AI

Is there any increased risk to healthy participants when taking part in the SAD trial (Part A)?

"Our assessment of Part A: SAD's safety rating for healthy participants is a 1 due to the preliminary nature of this Phase 1 trial, meaning there exists little data on both its efficacy and safety."

Answered by AI

Is my eligibility sufficient to partake in this scientific experiment?

"This medical study is seeking 90 individuals between the ages of 18-65 with chronic hepatitis b to participate. The body mass index should be 19-35 kg/m2 and their weight must exceed 45kg. Female volunteers who are not pregnant or trying to conceive must use two forms of contraception, one of which needs to be a barrier method like a condom for the duration of the trial plus three months after ceasing treatment. Men need agree to remain abstinent or use contraceptive measures until completion while also refraining from donating sperm. Participants will have had negative PCR tests prior to screening and require a clear RAT test at check in before signing"

Answered by AI

What is the aggregate figure of participants in this trial?

"Affirmative, the study is recruiting on clinicaltrials.gov and was first made available to prospective patients on February 28th 2023. The investigation has since been updated as recent as October 5th 2023 and requires 90 participants from 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B

2023. "A Study Evaluating AHB-137 in Healthy Participants and Participants With Chronic Hepatitis B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05717686.

All > Hepatitis B