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Study of AHB-171 in Chronic Hepatitis B Participants (EXTEND-101)

24. maj 2026 opdateret af: AusperBio Therapeutics Inc.

A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

144

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • New Zealand Clinical Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or female participants, aged 18-65 years old (inclusive)
  • Body Mass Index between 19 to 35 kg/m2 (inclusive)
  • Body weight > or = 45 kg.
  • Documented HBV infection for ≥6 months prior to randomization.
  • For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
  • For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.
  • Screening electrocardiogram (ECG) without clinically significant abnormalities
  • Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal).
  • Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.
  • Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.

Exclusion Criteria:

  • Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
  • Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
  • History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
  • Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
  • HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
  • Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.
  • Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).
  • Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).
  • History or signs of vasculitis or related autoimmune diseases.
  • Malignancy within 5 years (except non-melanoma skin cancer).
  • Allergy to study drug components.
  • Recent major surgery/trauma (within 3 months) or planned surgery during study.
  • Alcohol or substance abuse affecting compliance.
  • Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.
  • Participation in another clinical trial or recent investigational product use.
  • Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.
  • Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.
  • Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped).
  • Any other condition making the participant unsuitable (per investigator).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
Medicin: Nukleos(t)id-analog (NA)
Oral administration
Medicin: AHB-171
Injection
Medicin: Placebo matching [Investigational Product]
Injection
Eksperimentel: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
Medicin: Nukleos(t)id-analog (NA)
Oral administration
Medicin: AHB-171
Injection
Medicin: Placebo matching [Investigational Product]
Injection
Eksperimentel: AHB-171 and placebo in CHB (Part C: finite MD)
Medicin: AHB-171
Injection
Medicin: Placebo matching [Investigational Product]
Injection
Eksperimentel: AHB-171 and placebo in CHB (Part D: finite MD)
Medicin: AHB-171
Injection
Medicin: Placebo matching [Investigational Product]
Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Tidsramme: Up to 72 weeks
Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.
Tidsramme: Up to 72 weeks
Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171
Tidsramme: Up to 72 weeks
Up to 72 weeks
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Tidsramme: Up to 72 weeks
Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure
Up to 72 weeks
Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]
Tidsramme: Up to 72 weeks
12-lead electrocardiogram (ECG) abnormalities will be reported, with parameters evaluated including PR interval, QRS duration, QT/QTc interval.
Up to 72 weeks
Incidence of laboratory abnormalities [Safety and Tolerability]
Tidsramme: Up to 72 weeks
Up to 72 weeks
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171
Tidsramme: Up to 72 weeks
Up to 72 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
Tidsramme: Up to 72 weeks
Up to 72 weeks
Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants achieving HBsAg < or ≥ LOD (limit of detection) and/or HBV DNA < or ≥ LLOQ (lower limit of quantitation) across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study
Tidsramme: Up to 72 weeks
Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) levels
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants experiencing virologic relapse.
Tidsramme: Up to 72 weeks
Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
Up to 72 weeks
Time to participants experiencing virologic relapse.
Tidsramme: Up to 72 weeks
Virologic relapse is defined as HBV DNA meeting a protocol-specified threshold value at 2 consecutive visits
Up to 72 weeks
Proportion of participants with treatment emergent AEs (TEAEs), serious AEs (SAEs), or discontinuation due to AEs.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
Tidsramme: Up to 72 weeks
Up to 72 weeks
ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Plasma PK parameters AUC of AHB-171 and metabolites.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Plasma PK parameter Cmax of AHB-171 and metabolites.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study
Tidsramme: Up to 72 weeks
Up to 72 weeks
Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study.
Tidsramme: Up to 72 weeks
Up to 72 weeks
Absolute serum HBsAb (Hepatitis B surface Antibody) and change from baseline across all evaluated timepoints in the study.
Tidsramme: Time Frame: Up to 72 weeks
Time Frame: Up to 72 weeks
Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
Tidsramme: Up to 72 weeks
Up to 72 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AusperBio Therapeutics Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

6. juli 2026

Primær færdiggørelse (Anslået)

8. oktober 2027

Studieafslutning (Anslået)

14. august 2028

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

24. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AB-17-8001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

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Ingen

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Kliniske forsøg med Hepatitis B, kronisk

Kliniske forsøg med Nukleos(t)id-analog (NA)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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