Phase 2 Hepatitis B Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 to 45 years old (male or female).
• Men weighing at least 50 kg, or women weighing at least 45 kg, with a body mass index (BMI) between 18 and 28.
• People who have had a positive hepatitis B surface antigen (HBsAg) and/or detectable hepatitis B virus in the blood for 6 months or longer, or whose liver biopsy has previously confirmed chronic hepatitis B, or whose blood test shows no recent acute hepatitis B infection (confirm with trial site).
• People whose hepatitis B virus markers and liver function test results at the screening visit fall within the specific ranges required for one of three participant groups (cohorts) — the exact ranges differ by cohort and will be assessed by the trial site.
• People with specific prior treatment histories depending on the cohort: Cohorts 1 and 2 require no interferon treatment in the past year and no nucleoside/nucleotide antiviral medicines in the past 6 months; Cohort 3 requires no interferon in the past year and at least one year of treatment with a single nucleoside/nucleotide antiviral medicine.
• People who fully understand the study and are willing to sign a consent form.
• People who are able to communicate with the research team and follow the study requirements throughout.
• People who are not surgically sterilised, or women who have been through menopause for less than two years, who agree to use effective contraception from the screening visit until the last follow-up appointment.

Who may not be able to join:

• People who are also infected with hepatitis C, syphilis, or HIV.
• People whose blood test results at screening show certain abnormalities in liver function, blood cell counts, kidney function, blood sugar control, or clotting ability — the trial site will assess these specific values.
• People with clinically significant heart rhythm or electrical abnormalities on an ECG, or high blood pressure that remains poorly controlled despite medication.
• People with other significant liver conditions at the same time, such as moderate or severe fatty liver, alcoholic liver disease, autoimmune liver disease, inherited liver conditions, or medication-related liver damage.
• People who have a history of significant liver scarring (fibrosis) or cirrhosis at any point before or during screening.
• People who have ever had, or currently have, signs of liver failure such as fluid build-up in the abdomen, confusion caused by liver problems, bleeding from veins in the food pipe or stomach, or kidney failure related to liver disease.
• People who have previously had liver cancer, or whose screening results (blood test or imaging scan) suggest the possibility of liver cancer.
• People with serious conditions affecting other body systems, including heart disease (such as unstable angina or heart failure), severe lung disease, kidney disease, poorly controlled diabetes or thyroid problems, autoimmune diseases (such as lupus or rheumatoid arthritis), significant mental health conditions (such as epilepsy, schizophrenia, or depression), or any active cancer — the trial doctor will assess suitability on a case-by-case basis.
• Women who are pregnant or breastfeeding.
• People who have regularly consumed more than 40 g of alcohol per day (for men) or more than 20 g per day (for women), or who have used illicit drugs, in the 6 months before screening.
• People who have taken part in another clinical drug trial (where they received the investigational medicine) or an invasive medical device trial within the past 3 months.
• People who have had major injury or major surgery in the past 3 months.
• People with a known allergy to HH-003, HH-006, or polysorbate 80.
• People whom the investigator considers unsuitable for the study for any other reason, or who have a close personal or professional relationship with the trial site — for example, immediate family members of the investigator or staff and students at the trial site.

Important: Always verify eligibility with the trial site directly before applying.