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Study of AHB-171 in Chronic Hepatitis B Participants

20. juli 2026 oppdatert av: Ausper Biopharma Co., Ltd.

An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B

The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

138

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

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:

  • Able to fully understand and sign the informed consent form (ICF).
  • Male or female participants, aged 18-65 years (inclusive).
  • Body mass index (BMI) meeting the predefined eligibility range.
  • Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
  • At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements.
  • Adopt effective contraceptive measures as required

Exclusion Criteria:

  • History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
  • Prior history of solid organ or hematopoietic stem cell transplantation.
  • History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
  • History or presence of hepatic decompensation at screening.
  • History of primary liver cancer, or diagnosis/suspected liver cancer at screening.
  • Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening
  • History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation.
  • Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection).
  • History of drug abuse, or alcoholism.
  • Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period.
  • Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening.
  • Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening.
  • Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period.
  • Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions.
  • Clinically significant abnormal electrocardiogram (ECG) at screening.
  • Tested positive for HIV，HCV or active syphilis infection.
  • Uncontrolled hypertension at screening.
  • Clinically significant abnormal laboratory test as specified in protocol at screening.
  • Currently participating in another clinical trials, or within the washout period.
  • Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AHB-171 in Treatment CHB
Legemiddel: AHB-171 Injection
Subcutaneous injection
Eksperimentell: AHB-171 in Naïve CHB
Legemiddel: AHB-171 Injection
Subcutaneous injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)
Tidsramme: Up to 90 days
Up to 90 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit
Tidsramme: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBsAg at each visit
Tidsramme: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBV RNA at each visit
Tidsramme: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBcrAg at each visit
Tidsramme: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBeAg at each visit
Tidsramme: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBeAb at each visit
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization
Tidsramme: Up to 90 days
Up to 90 days
Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
Tidsramme: Up to 90 days
CTCAE will be used to describe severity.
Up to 90 days
Proportion of participants with clinically significant abnormalities in laboratory tests
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with clinically significant abnormalities in ECG
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with clinically significant abnormalities in physical examinations and vital signs
Tidsramme: Up to 90 days
Up to 90 days
Changes in ECG from baseline
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL
Tidsramme: Up to 90 days
Up to 90 days
Plasma concentration of AHB-171 at different time points
Tidsramme: Up to 90 days
Up to 90 days
Proportion of participants with detectable anti-drug antibody (ADA)
Tidsramme: Up to 90 days
Up to 90 days
Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
Tidsramme: Up to 90 days
Up to 90 days

Samarbeidspartnere og etterforskere

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

Sponsor

Ausper Biopharma Co., Ltd.

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 (Faktiske)

24. juni 2026

Primær fullføring (Antatt)

31. mars 2029

Studiet fullført (Antatt)

31. mai 2029

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AB-17-8003

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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