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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Subcutaneous injection
AusperBio Investigational Site
Jilin City, Jilin, China
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)
Time frame: Up to 90 days
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
Time frame: Up to 90 days
Reduction of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
Time frame: 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
Time frame: Up to 90 days
Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit
Time frame: Up to 90 days
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
Time frame: Up to 90 days
Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit
Time frame: Up to 90 days
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit
Time frame: Up to 90 days
Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBsAg at each visit
Time frame: Up to 90 days
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Absolute or log change from baseline for HBV RNA at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBcrAg at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBeAg at each visit
Time frame: Up to 90 days
Absolute or log change from baseline for HBeAb at each visit
Time frame: Up to 90 days
Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization
Time frame: Up to 90 days
Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
CTCAE will be used to describe severity.
Time frame: Up to 90 days
Proportion of participants with clinically significant abnormalities in laboratory tests
Time frame: Up to 90 days
Proportion of participants with clinically significant abnormalities in ECG
Time frame: Up to 90 days
Proportion of participants with clinically significant abnormalities in physical examinations and vital signs
Time frame: Up to 90 days
Changes in ECG from baseline
Time frame: Up to 90 days
Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL
Time frame: Up to 90 days
Plasma concentration of AHB-171 at different time points
Time frame: Up to 90 days
Proportion of participants with detectable anti-drug antibody (ADA)
Time frame: Up to 90 days