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

24. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

144

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
Arzneimittel: Nukleos(t)id-Analogon (NA)
Orale Verabreichung
Arzneimittel: AHB-171
Injection
Arzneimittel: Placebo matching [Investigational Product]
Injection
Experimental: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
Arzneimittel: Nukleos(t)id-Analogon (NA)
Orale Verabreichung
Arzneimittel: AHB-171
Injection
Arzneimittel: Placebo matching [Investigational Product]
Injection
Experimental: AHB-171 and placebo in CHB (Part C: finite MD)
Arzneimittel: AHB-171
Injection
Arzneimittel: Placebo matching [Investigational Product]
Injection
Experimental: AHB-171 and placebo in CHB (Part D: finite MD)
Arzneimittel: AHB-171
Injection
Arzneimittel: Placebo matching [Investigational Product]
Injection

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: Up to 72 weeks
Up to 72 weeks
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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
Zeitfenster: Up to 72 weeks
Up to 72 weeks

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AusperBio Therapeutics Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

6. Juli 2026

Primärer Abschluss (Geschätzt)

8. Oktober 2027

Studienabschluss (Geschätzt)

14. August 2028

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AB-17-8001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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