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

24. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

144

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
Legemiddel: Nukleos(t)idanalog (NA)
Oral administrering
Legemiddel: AHB-171
Injection
Legemiddel: Placebo matching [Investigational Product]
Injection
Eksperimentell: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
Legemiddel: Nukleos(t)idanalog (NA)
Oral administrering
Legemiddel: AHB-171
Injection
Legemiddel: Placebo matching [Investigational Product]
Injection
Eksperimentell: AHB-171 and placebo in CHB (Part C: finite MD)
Legemiddel: AHB-171
Injection
Legemiddel: Placebo matching [Investigational Product]
Injection
Eksperimentell: AHB-171 and placebo in CHB (Part D: finite MD)
Legemiddel: AHB-171
Injection
Legemiddel: Placebo matching [Investigational Product]
Injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AusperBio Therapeutics Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

6. juli 2026

Primær fullføring (Antatt)

8. oktober 2027

Studiet fullført (Antatt)

14. august 2028

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

24. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AB-17-8001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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