Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

24 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

144

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Hongkong
      • Hong Kong, Hongkong
        • Queen Mary Hospital
  • Nieuw-Zeeland
    • Auckland
      • Grafton, Auckland, Nieuw-Zeeland, 1010
        • New Zealand Clinical Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
Geneesmiddel: Nucleos(t)ide Analoog (NA)
Orale toediening
Geneesmiddel: AHB-171
Injection
Geneesmiddel: Placebo matching [Investigational Product]
Injection
Experimenteel: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
Geneesmiddel: Nucleos(t)ide Analoog (NA)
Orale toediening
Geneesmiddel: AHB-171
Injection
Geneesmiddel: Placebo matching [Investigational Product]
Injection
Experimenteel: AHB-171 and placebo in CHB (Part C: finite MD)
Geneesmiddel: AHB-171
Injection
Geneesmiddel: Placebo matching [Investigational Product]
Injection
Experimenteel: AHB-171 and placebo in CHB (Part D: finite MD)
Geneesmiddel: AHB-171
Injection
Geneesmiddel: Placebo matching [Investigational Product]
Injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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
Tijdsspanne: Up to 72 weeks
Up to 72 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) levels
Tijdsspanne: 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.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Proportion of participants experiencing virologic relapse.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Plasma PK parameters AUC of AHB-171 and metabolites.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Plasma PK parameter Cmax of AHB-171 and metabolites.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
Tijdsspanne: Up to 72 weeks
Up to 72 weeks
Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: Time Frame: Up to 72 weeks
Time Frame: Up to 72 weeks
Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
Tijdsspanne: Up to 72 weeks
Up to 72 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AusperBio Therapeutics Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

6 juli 2026

Primaire voltooiing (Geschat)

8 oktober 2027

Studie voltooiing (Geschat)

14 augustus 2028

Studieregistratiedata

Eerst ingediend

7 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

24 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AB-17-8001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren