This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).
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Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration.
Timeframe: 2 weeks
Rate and severity of treatment-emerging unsolicited adverse events that are Grade 2 or above (including confirmed laboratory abnormalities) within 2, 12, 24 and 48 weeks after administration.
Timeframe: 48 weeks
Rate and severity of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and the duration of those SAEs.
Timeframe: 48 weeks
Rate and severity of participants with potential immune complex disease (ICD) throughout the study period following investigational product (IP) administration.
Timeframe: 48 weeks
Changes in AST within 2,12, 24 and 48 weeks after administration.
Timeframe: 48 weeks
Changes in ALT within 2,12, 24 and 48 weeks after administration
Timeframe: 48 weeks
Changes in alkaline phosphatase within 2,12, 24 and 48 weeks after administration
Timeframe: 48 weeks
Changes in bilirubin within 2,12, 24 and 48 weeks after administration
Timeframe: 48 weeks
Changes in albumin within 2,12, 24 and 48 weeks after administration
Timeframe: 48 weeks
Elimination half-life of HepB mAb19
Timeframe: 48 weeks
Clearance (CL/F) of HepB mAb19
Timeframe: 48 weeks
Volume of Distribution (Vz/F) of HepB mAb19
Timeframe: 48 weeks
Area under the curve (AUC) of HepB mAb19
Timeframe: 48 weeks
Decay Curve of HepB mAb19
Timeframe: 48 weeks