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

NCT05717686 | Completed Phase 1 FDA Drug

• 1 other identifier: AB-10-8001
• Study Type: interventional
• Target: 64
• Locations: 4 countries
• Sites: 9

Brief 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. In addition, the study will evaluate the initial antiviral efficacy of AHB-137 in CHB patients following a multiple dosing regimen.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

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

  Up to 30 days for SAD, up to 113 days for MD

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

  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.

  Up to 204 days

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

  Up to 204 days

• The pharmacokinetic profile of AHB-137: the maximum observed plasma concentration (Cmax) of AHB-137

  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

  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

  Up to 30 days for SAD; up to 204 days for MD

Study Arms (4)

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.

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.

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.

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).

Drug: AHB-137 injection; Drug: Placebo

Interventions

AHB-137 injection DRUG

AHB-137 will be administered

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

Placebo DRUG

Placebo will be administered

Part A: SAD in healthy participants; Part B: MD in healthy participants; Part D: MD in CHB patients in multiple centers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• AusperBio Therapeutics Inc.: lead

Study Sites (9)

Stanford Medicine

Redwood City, California, 94063, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

American Research Corporation

Houston, Texas, 78215, United States

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

New Zealand Clinical Research

Grafton, Auckland, 1010, New Zealand

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 80756, Taiwan

Location

E-DA Hospital

Kaohsiung, Taiwan, 82445, Taiwan

Location

Chia-Yi Christian Hospital

Chiayi City, 60002, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ed Gane

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 8, 2023
• Study Start: February 28, 2023
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); TW (3); US (4); NZ (1)