Phase II Clinical Study to Evaluate the Efficacy and Safety of Multiple Dosing of HH-006 in Patients With Chronic Hepatitis B Virus Infection
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;
• Virological and liver function indicators at screening:
⁃ Cohort 1: HBeAg-positive, 2000 IU/mL ≤ HBsAg ≤ 100,000 IU/mL, HBV DNA \> 105 IU/mL, 2 × upper limit of normal (ULN) ≤ ALT ≤ 8 × ULN; Cohort 2: HBeAg-negative, 100 IU/mL ≤ HBsAg ≤ 3000 IU/mL, 20 IU/mL \< HBV DNA ≤ 2000 IU/mL, ALT ≤ 5 × ULN; Cohort 3: HBeAg-negative, 100 IU/mL ≤ HBsAg ≤ 3000 IU/mL, HBV DNA ≤ 100 IU/mL, ALT ≤ 2 × ULN;
• Previous antiviral treatment:
⁃ Cohort 1 and Cohort 2: No interferon antiviral treatment within the past 1 year, and no nucleos(t)ide analogue (NA) treatment within the 6 months prior to screening; Cohort 3: No interferon antiviral treatment within the past 1 year; received only nucleos(t)ide analogue monotherapy for at least one year;
• Fully understand the study content, procedures, and possible adverse reactions, and sign the written informed consent form (ICF);
• Able to communicate effectively with the investigator and complete the study in accordance with the study requirements;
• Male subjects who have not undergone sterilization and female subjects who have been postmenopausal for less than two years must agree to take adequate and effective contraceptive measure from screening until the last follow-up visit.