Study HH006-202 is designed to assesses the efficacy and safety of HH-006 in adults chronic HBV infection. Eligible participants will receive study treatment for 48 weeks. All treated patients will also undergo a follow-up period after last study drug treatment.
Sex: male or female; Age: 18 to 45 years old (inclusive);
Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI): 18 kg/m² ≤ BMI ≤ 28 kg/m²;
HBsAg and/or HBV DNA positivity for more than 6 months (including 6 months), or previous liver biopsy results indicating chronic hepatitis B, or negative for anti-HBc IgM;
Fully understand the study content, procedures, and possible adverse reactions, and sign the written informed consent form (ICF);
Co-infected with hepatitis C, syphilis, or human immunodeficiency virus (HIV);
At screening: total bilirubin ≥ 3 × ULN and direct bilirubin (DBil) > 1 × ULN; hemoglobin < 100 g/L; platelet count < 100,000/mm³ (100 × 109/L); absolute neutrophil count < 1,500/mm³ (1.5 × 109/L); serum albumin < 35 g/L; prothrombin time international normalized ratio (INR) > 1.3; glycated hemoglobin (HbA1c) ≥ 7%; estimated glomerular filtration rate (eGFR) (MDRD formula) < 60 mL/min/1.73 m² (Appendix 2 MDRD calculation formula);
Clinically significant electrocardiogram (ECG) abnormalities (e.g., QTcF > 450 ms in males, > 470 ms in females, severe arrhythmias such as torsade de pointes, paroxysmal ventricular tachycardia, symptomatic atrial fibrillation/flutter requiring emergency treatment, complete atrioventricular block); poorly controlled or refractory hypertension (e.g., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg after medication use, etc.);
Concurrent clinically significant other liver diseases, including but not limited to: moderate or severe fatty liver, alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, drug-induced liver injury, etc.;
Single group
HH-006
Biological/VaccineHH-006 480 mg SC injection every one week for 4 weeks and followed by 240 mg QW for 44 weeks
HBsAg change from baseline
value of HBsAg change from baseline
HBsAg change from baseline
value of HBsAg change from baseline
proportion of HBsAg loss
number of participants with HBsAg loss
HBsAg change from baseline
value of HBsAg change from baseline
cohort 1and cohort 2: proportion of HBV DNA decreasing more than 1 log10/mL
number of participants with HBV DNA decreasing more than 1 log10/mL
Click on the lead sponsor to view all of their trials.
