This study is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection on NAs background treatment in CHB participants.
The study consists of screening period, treatment period, and FU period. It is divided into 3 dose groups, namely 100 mg Q4W, 200 mg Q4W and 200 mg Q12W. Each group will enroll 16 eligible participants, with 12 participants receiving RBD1016 injection and 4 participants receiving placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
RBD1016 with NAs background treatment will be explored.
Prince of Wales Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Clinical Trial Consultants AB
Uppsala, Uppsala County, Sweden
safety: number and percentage of AEs
Number and percentage of participants with adverse events (AEs). All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).
Time frame: 24 weeks
efficacy: the maximum decline of HBsAg level
The maximum decline (log value) of HBsAg level. Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
Time frame: 24 weeks
efficacy: the proportion of HBsAg decline≥1 log10 IU/mL
The proportion of participants with HBsAg decline ≥1 log10 IU/mL. Electro chmiluminescence method will be used to detect HBsAg.
Time frame: 24 weeks
PK parameter Cmax
Maximum concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Time frame: 12 weeks
PK parameter Tmax
Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter.
Time frame: 12 weeks
PK parameter AUC0-t
Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Time frame: 12 weeks
PK parameter t1/2
Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK parameter Vd/F
Apparent volume of distribution (Vd/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Time frame: 12 weeks
PK parameter CL/F
Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Time frame: 12 weeks
PK parameter Css
Steady state concentration (Css) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Time frame: 12 weeks