Chronic hepatitis B
Conditions
Brief summary
Primary safety endpoint: Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) up to follow-up (FU) Week 24., Primary efficacy endpoint: The maximum decline (log value) of HBsAg level from baseline up to FU Week 24.
Detailed description
1) The proportion of participants with HBsAg decline ≥1 log10 IU/mL from baseline to FU Week 24;, 2) PK parameters for RBD1016 and its metabolites, including but not limited to maximum concentration (Cmax), time to maximum concentration (Tmax), area under curve (AUC0-t, AUC0-inf), elimination half-life (t1/2), terminal rate constant (λz), apparent volume of distribution (Vd/F), apparent clearance (CL/F), steady state concentration (Css) up to FU Week 12.
Interventions
DRUGlight yellow transparent clear solution
DRUG1 ml per vial
DRUGcontaining 4 μg of vitamin B2 (for coloring purpose only
DRUGinactive at this concentration)
DRUGwith the same appearance as RBD1016 injection
DRUGfor subcutaneous injection.
Sponsors
Suzhou Ribo Life Science Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) up to follow-up (FU) Week 24., Primary efficacy endpoint: The maximum decline (log value) of HBsAg level from baseline up to FU Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The proportion of participants with HBsAg decline ≥1 log10 IU/mL from baseline to FU Week 24;, 2) PK parameters for RBD1016 and its metabolites, including but not limited to maximum concentration (Cmax), time to maximum concentration (Tmax), area under curve (AUC0-t, AUC0-inf), elimination half-life (t1/2), terminal rate constant (λz), apparent volume of distribution (Vd/F), apparent clearance (CL/F), steady state concentration (Css) up to FU Week 12. | — |
Countries
Sweden
Outcome results
None listed