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Study of AHB-171 in Chronic Hepatitis B Participants

20 juli 2026 uppdaterad 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)

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

138

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: AHB-171 in Treatment CHB
Läkemedel: AHB-171 Injection
Subcutaneous injection
Experimentell: AHB-171 in Naïve CHB
Läkemedel: AHB-171 Injection
Subcutaneous injection

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
Tidsram: 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
Tidsram: 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
Tidsram: Up to 90 days
Up to 90 days
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
Tidsram: Up to 90 days
Up to 90 days
Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit
Tidsram: 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
Tidsram: 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
Tidsram: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBsAg at each visit
Tidsram: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBV RNA at each visit
Tidsram: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBcrAg at each visit
Tidsram: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBeAg at each visit
Tidsram: Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBeAb at each visit
Tidsram: Up to 90 days
Up to 90 days
Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization
Tidsram: Up to 90 days
Up to 90 days
Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
Tidsram: 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
Tidsram: Up to 90 days
Up to 90 days
Proportion of participants with clinically significant abnormalities in ECG
Tidsram: Up to 90 days
Up to 90 days
Proportion of participants with clinically significant abnormalities in physical examinations and vital signs
Tidsram: Up to 90 days
Up to 90 days
Changes in ECG from baseline
Tidsram: Up to 90 days
Up to 90 days
Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL
Tidsram: Up to 90 days
Up to 90 days
Plasma concentration of AHB-171 at different time points
Tidsram: Up to 90 days
Up to 90 days
Proportion of participants with detectable anti-drug antibody (ADA)
Tidsram: Up to 90 days
Up to 90 days
Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
Tidsram: Up to 90 days
Up to 90 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ausper Biopharma Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juni 2026

Primärt slutförande (Beräknad)

31 mars 2029

Avslutad studie (Beräknad)

31 maj 2029

Studieregistreringsdatum

Först inskickad

2 juni 2026

Först inskickad som uppfyllde QC-kriterierna

2 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AB-17-8003

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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