Brief Summary

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)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

138

participants targeted

Target at P75+ for phase_2

Timeline

35mo left

Started Jun 2026

Typical duration for phase_2

Geographic Reach

1 country

10 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Progress4%

Jun 2026May 2029

First Submitted

Initial submission to the registry

June 2, 2026

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed

19 days until next milestone

Study Start

First participant enrolled

June 24, 2026

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

June 2, 2026

Last Update Submit

July 20, 2026

Conditions

Hepatitis B, Chronic (CHB)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (22)

Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
Up to 90 days
Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
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
Up to 90 days
Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit
Up to 90 days
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
Up to 90 days
+17 more secondary outcomes

Study Arms (2)

AHB-171 in Treatment CHB

EXPERIMENTAL

Drug: AHB-171 Injection

AHB-171 in Naïve CHB

EXPERIMENTAL

Drug: AHB-171 Injection

Interventions

AHB-171 InjectionDRUG

Subcutaneous injection

AHB-171 in Naïve CHBAHB-171 in Treatment CHB

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.
+5 more criteria

Contact the study team to confirm eligibility.