Phase 1 Hepatitis B Trial, Completed

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

Who might be able to join this trial:

Part 1 – Healthy volunteers only:

• People with no signs of any active or long-term illness, confirmed through medical history, physical examination, heart tracing (ECG), and blood and urine tests
• People with a body weight in the healthy range (BMI between 18 and 30)
• Women who have had a surgical procedure to prevent pregnancy, or who have been through menopause for at least one year
• Men who agree to either avoid sexual activity or use contraception during the trial, and agree not to donate sperm

Part 2 – People with chronic Hepatitis B (HBV) infection only:

• People with a BMI between 18 and 30
• People who have tested positive for Hepatitis B surface antigen (a marker of HBV infection) for more than 6 months
• People whose HBV virus levels in the blood meet specific minimum thresholds at screening, depending on a particular HBV marker result (confirm exact values with trial site)
• People who have had a liver assessment (such as a biopsy, fibroscan, or similar test) within the past 6 months showing liver disease from HBV, but without severe scarring or cirrhosis
• Men who agree to either avoid sexual activity or use contraception, and agree not to donate sperm
• Women who could become pregnant and agree to either avoid sexual activity or use non-hormonal contraception with a very high success rate, during treatment and for at least 3 months after the last dose

Part 3 – People with chronic Hepatitis B (HBV) infection only:

• People with a BMI between 18 and 32
• People who have tested positive for HBV markers for more than 6 months before screening
• For certain groups in this part: people who have been treated with a single specific antiviral medication (entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate) for at least 12 months, and on the same medication for at least 3 months before screening (confirm with trial site which group applies)
• For other groups in this part: people who have had no more than 30 days total of prior HBV treatment, and no HBV treatment in the 3 months before the first study dose (confirm with trial site which group applies)
• People who have had a liver assessment (biopsy, fibroscan, or similar test) within the past 6 months showing liver disease from HBV, but without severe scarring or cirrhosis
• Men who agree to either avoid sexual activity or use contraception, and agree not to donate sperm
• Women who could become pregnant and agree to either avoid sexual activity or use two approved forms of contraception during the study and for at least 6 months after the last dose

Who may not be able to join:

Part 1 – Healthy volunteers only:

• People with a history of significant illness affecting the gut, kidneys, liver, lungs, nervous system, heart, hormones, blood, or immune system, or who have had cancer or cirrhosis
• People with a history of Gilbert's syndrome (a liver condition affecting how the body processes bilirubin)
• People who have had a notable illness such as flu, a local infection, or stomach illness within two weeks before the dose
• People who have had a serious allergic reaction (such as hives or anaphylaxis) to any medication, or who have had multiple drug allergies
• People with any significant ongoing health condition that could interfere with the study or pose a risk, in the opinion of the study doctor
• People who test positive at screening for Hepatitis A, Hepatitis B, Hepatitis C, or HIV
• People with a specific type of eye condition called acute narrow-angle glaucoma (for certain groups in this part only)

Part 2 – People with chronic HBV infection only:

• People who have had bleeding from veins in the food pipe (oesophagus)
• People who have liver cirrhosis or signs of serious liver failure, such as fluid build-up in the abdomen, swollen veins, an enlarged spleen, yellowing of the skin or eyes, or confusion caused by liver disease
• People with a liver condition caused by something other than HBV, such as an iron storage disorder, autoimmune liver disease, alcohol-related liver disease, or other causes
• People with a history of a liver condition related to metabolism within the past year
• People who test positive for Hepatitis A, C, D, or HIV
• People with a history of, or suspicion of, liver cancer, or abnormal liver cancer marker levels in the blood at screening
• People with a significant history of gut, heart, hormone, kidney, eye, lung, psychiatric, or neurological disease
• People who have had an organ transplant
• People who have received HBV treatment in the past 6 months
• People who have had a significant infection or serious illness within 2 weeks before joining

Part 3 – People with chronic HBV infection only:

• People who have had bleeding from veins in the food pipe (oesophagus)
• People who have liver cirrhosis or signs of serious liver failure, such as fluid build-up in the abdomen, swollen veins, an enlarged spleen, yellowing of the skin or eyes, or confusion caused by liver disease
• People with a liver condition caused by something other than HBV (such as an iron storage disorder, autoimmune liver disease, alcohol-related liver disease, or other causes)
• People with a thyroid condition that is not well controlled with medication, or with notably abnormal thyroid test results
• People with a history of a liver condition related to metabolism within the past year
• People who test positive for Hepatitis A, C, D, E, or HIV
• People with a diagnosis or suspicion of liver cancer
• People with a significant history of gut, heart, hormone, kidney, eye, lung, psychiatric, or neurological disease
• People who have had an organ transplant
• People who have had a significant infection or serious illness within 2 weeks before screening

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