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
Beijing, Beijing Municipality, China
RECRUITINGAusperBio Investigational Site
Chongqing, Chongqing Municipality, China
RECRUITINGProportion 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
Change 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AusperBio Investigational Site
Xiamen, Fujian, China
AusperBio Investigational Site
Guangzhou, Guangdong, China
RECRUITINGAusperBio Investigational Site
Nanning, Guangxi, China
RECRUITINGAusperBio Investigational Site
Zhengzhou, Henan, China
RECRUITINGAusperBio Investigational Site
Changzhou, Jiangsu, China
RECRUITINGAusperBio Investigational Site
Jilin City, Jilin, China
RECRUITINGAusperBio Investigational Site
Chengdu, Sichuang, China
RECRUITINGAusperBio Investigational Site
Hangzhou, Zhejiang, China
RECRUITINGAbsolute 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