A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia

Korábbi kezelés

• History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ;
• History or evidence of hepatocellular carcinoma at any time prior to or at time of screening;

Más betegség

• History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;

Laborértékek

• Exclusionary laboratory results at screening: total bilirubin >2xULN or direct bilirubin >1.5xULN，hemoglobin <120 g/L for males or <110 g/L ro females，platelets count<100,000/mm\^3 (100×10\^9/L), and absolute neutrophils count <1,500/mm\^3 (1.5×10\^9/L).

Egyéb

• Females who are pregnant or lactating at screening;

• Signed informed consent form;
• Male or female aged from 18 to 60 years (inclusively);
• 18 kg/m\^2≤BMI≤30 kg/m\^2, body weight≥50 kg for men and ≥45 kg for women;
• Subjects who have chronic HBV infection greater than or equal to 6 months at screening;
• 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤2000 IU/mL; ALT≤3×ULN;
• Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening.