Study of AHB-171 in Chronic Hepatitis B Participants (EXTEND-101)
24 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
144
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Debbie Liao
- Numéro de téléphone: (650) 650-2877
- E-mail: ausperbioclinicaltrials@ausperbio.com
Lieux d'étude
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Auckland
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Grafton, Auckland, Nouvelle-Zélande, 1010
- New Zealand Clinical Research
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: AHB-171 or Placebo in CHB (Part A: Single Ascending Dose [SAD])
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Administration orale
Injection
Injection
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Expérimental: AHB-171 or Placebo in CHB (Part B: finite Multiple Dose [MD])
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Administration orale
Injection
Injection
|
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Expérimental: AHB-171 and placebo in CHB (Part C: finite MD)
|
Injection
Injection
|
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Expérimental: AHB-171 and placebo in CHB (Part D: finite MD)
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Injection
Injection
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Adverse Events (AEs) [Safety and Tolerability]
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171
Délai: Up to 72 weeks
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Up to 72 weeks
|
|
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Incidence of clinically significant changes in Vital Signs [Safety and Tolerability]
Délai: Up to 72 weeks
|
Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure
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Up to 72 weeks
|
|
Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability]
Délai: 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]
Délai: 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
Délai: Up to 72 weeks
|
Up to 72 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study
Délai: Up to 72 weeks
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Up to 72 weeks
|
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Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study.
Délai: Up to 72 weeks
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Up to 72 weeks
|
|
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Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study.
Délai: 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.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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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.
Délai: Up to 72 weeks
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Up to 72 weeks
|
|
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Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study.
Délai: Up to 72 weeks
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Up to 72 weeks
|
|
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Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study
Délai: Up to 72 weeks
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Up to 72 weeks
|
|
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Change from baseline in alanine aminotransferase (ALT) levels
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study.
Délai: Up to 72 weeks
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Up to 72 weeks
|
|
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Proportion of participants experiencing virologic relapse.
Délai: 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
|
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Time to participants experiencing virologic relapse.
Délai: 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.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Proportion of participants with anti-drug antibodies (ADA) to AHB-171.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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ADA titers in participants with ADA to AHB-171 across all evaluated timepoints in the study.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Plasma PK parameters AUC of AHB-171 and metabolites.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Plasma PK parameter Cmax of AHB-171 and metabolites.
Délai: Up to 72 weeks
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Up to 72 weeks
|
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Plasma PK parameter Time to Peak Concentration (tmax) of AHB-171 and metabolites.
Délai: Up to 72 weeks
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Up to 72 weeks
|
|
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Plasma PK parameter apparent clearance (CL [clearance]/F [Bioavailability]) of AHB-171 and metabolites.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Urine PK parameter cumulative amount excreted (Ae) of AHB-171 and metabolites.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Urine PK parameter renal clearance (CLr) of AHB-171 and metabolites.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Absolute serum HBV ribonucleic acid (RNA) and change from baseline across all evaluated timepoints in the study.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Absolute serum HBcrAg (Hepatitis B core-related antigen) and change from baseline across all evaluated timepoints in the study
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Absolute serum HBeAg (Hepatitis B e antigen) and change from baseline across all evaluated timepoints in the study.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Proportion of participants with hs-HBsAg (high-sensitivity HBsAg) <LLOQ across all evaluated timepoints in the study.
Délai: Up to 72 weeks
|
Up to 72 weeks
|
|
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Absolute serum HBsAb (Hepatitis B surface Antibody) and change from baseline across all evaluated timepoints in the study.
Délai: Time Frame: Up to 72 weeks
|
Time Frame: Up to 72 weeks
|
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Time to first hs-HBsAg <LLOQ, assessed at scheduled visits
Délai: Up to 72 weeks
|
Up to 72 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
6 juillet 2026
Achèvement primaire (Estimé)
8 octobre 2027
Achèvement de l'étude (Estimé)
14 août 2028
Dates d'inscription aux études
Première soumission
7 mai 2026
Première soumission répondant aux critères de contrôle qualité
24 mai 2026
Première publication (Réel)
1 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Infections
- Maladies virales
- Maladies du système digestif
- Maladies du foie
- Hépatite, virale, humaine
- Maladies transmissibles
- Infections par le virus de l'ADN
- Infections à Hépadnaviridae
- Hépatite chronique
- Hépatite
- Conditions pathologiques, signes et symptômes
- Hépatite B
- Hépatite B chronique
Autres numéros d'identification d'étude
- AB-17-8001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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