Phase 1 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:

This trial has two parts. Part A is for healthy volunteers, and Part B is for people with chronic hepatitis B.

Part A – Healthy Volunteers

Who might be able to join this trial:

• People aged 18 to 70 years, male or female, who are able and willing to sign a consent form
• Women who are either not able to become pregnant, or who are not currently pregnant or breastfeeding and are willing to use a highly effective form of contraception; men whose partners could become pregnant must either have had a sterilisation procedure or be willing to use a highly effective form of contraception
• People who have a clear, tattoo-free area of skin suitable for an injection under the skin, as assessed by the trial doctor

Who may not be able to join:

• People who have had major surgery under general anaesthetic within the past 12 weeks, or who expect to have such surgery during the trial
• People with a history of severe allergic reactions or anaphylaxis, or known sensitivity to the trial medicine or its ingredients
• People who have donated blood or lost 450 mL or more of blood in the past 4 weeks, or donated plasma in the 7 days before the first dose
• People who have any underlying medical condition, including conditions affecting the stomach or bowels, kidneys, liver, nervous system, blood, hormones, lungs, immune system, heart, or mental health
• People with a history of cancer, except for certain non-melanoma skin cancers removed more than one year before the screening visit, or a specific type of cervical cell change that was successfully treated more than five years before screening
• People with a current hepatitis A, B, or C infection
• People who test positive for HIV
• People with an active infection currently being treated with antiviral or antibiotic medicine that will not be finished at least two weeks before the first dose
• People with certain heart-related abnormalities on their screening heart tracing (ECG), a history of irregular heart rhythms, certain heart risk factors, or a specific heart measurement (QTcF) above 450 ms for men or 470 ms for women
• People whose physical examination results are considered clinically significant by the trial doctor
• People with significantly abnormal vital signs (such as blood pressure or heart rate)
• People with significantly abnormal blood test results at screening; from a certain stage of the trial onwards, people with low platelet counts or low neutrophil counts will also not be eligible
• People who have taken any prescription or over-the-counter medicines, vitamins, or herbal products within 2 weeks before the first dose (or longer, depending on how long the medicine stays in the body)
• People with a history or suspicion of drug or alcohol misuse within the past year
• People who are pregnant, planning to become pregnant during the trial, or currently breastfeeding
• People who smoke or use nicotine products equivalent to more than 5 cigarettes a day in the 3 months before screening, or who are unwilling to avoid nicotine products for 48 hours before and during their stay at the clinic
• People who have taken part in another clinical drug trial within the past 90 days, or more than 4 interventional trials in the past year; people who have had an invasive medical device implanted within the past 90 days that might affect their ability to complete the trial
• People who have received a live vaccine within 28 days before screening, or who plan to receive one within 28 days of the first dose (COVID-19 vaccines are not considered live vaccines)
• People whose urine drug screen tests positive for substances including cannabis, cocaine, amphetamines, or opiates (among others)
• People who test positive for alcohol at the screening visit or on the day before the first dose
• People who have drunk more than an average of 2 standard drinks of alcohol per day in the 90 days before screening

Part B – People with Chronic Hepatitis B

Who might be able to join this trial:

• People aged 18 to 70 years, male or female, who are able and willing to sign a consent form
• People with a body mass index (a measure of weight relative to height) between 18 and 35
• Women who are either not able to become pregnant, or who are not currently pregnant or breastfeeding and are willing to use a highly effective form of contraception; men whose partners could become pregnant must either have had a sterilisation procedure or be willing to use a highly effective form of contraception
• People who have been diagnosed with chronic hepatitis B, are negative for a certain hepatitis B marker (HBeAg, confirmed on two occasions at least 6 months apart), and have a certain level of hepatitis B surface antigen (HBsAg) of 100 IU/mL or above at screening
• People who have never been treated for hepatitis B, or who have not used approved or investigational hepatitis B medicines within the 12 months before joining the trial
• People whose vital signs and physical examination are normal, or where any abnormal results are not considered clinically significant by the trial doctor

Who may not be able to join:

• People with liver disease caused by something other than hepatitis B, such as hepatitis A, C, D, or E, alcohol-related liver disease, autoimmune hepatitis, or several other specific liver conditions (people with a fatty liver condition without inflammation, or with a confirmed condition called Gilbert's Syndrome, may still be eligible — confirm with trial site)
• People who have been diagnosed with or are suspected of having liver cancer
• People with significant liver scarring or cirrhosis, based on specific scan or biopsy results within the required timeframe (confirm with trial site)
• People who test positive for HIV at screening
• People with an active infection currently being treated with antiviral or antibiotic medicine that will not be finished at least two weeks before the first dose
• People with certain abnormal blood test results at screening, including high liver enzyme levels, low platelet counts, low neutrophil counts, low haemoglobin, abnormal bilirubin levels, low albumin, reduced kidney function, or an elevated clotting measure (confirm with trial site for specific values)
• People with a history of severe allergic reactions or anaphylaxis, or known sensitivity to the trial medicine or its ingredients
• People who have donated blood or lost 450 mL or more of blood in the past 4 weeks, or donated plasma in the 7 days before the first dose
• People with a history or current diagnosis of immune-related diseases such as lupus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, moderate-to-severe psoriasis, or autoimmune eye disease; or certain heart, lung, kidney, thyroid, or seizure conditions; or positive results for certain thyroid antibody tests
• People with significant heart, lung, kidney, digestive, hormonal, blood, or neurological conditions that could affect how the body processes the medicine or could affect safety or the interpretation of results
• People with certain heart-related abnormalities on their screening ECG, a history of irregular heart rhythms, certain heart risk factors, or a specific heart measurement (QTcF) above 450 ms for men or 470 ms for women
• People whose physical examination results are considered clinically significant by the trial doctor
• People with significantly abnormal vital signs, confirmed after at least 5 minutes of additional rest
• People who have drunk more than an average of 2 standard drinks of alcohol per day in the 90 days before screening
• People who test positive for alcohol at the screening visit or on the first day of dosing; alcohol must be avoided for at least 48 hours before each dose and during any clinic stay
• People who smoke or use nicotine products equivalent to more than 5 cigarettes per day in the 3 months before screening; nicotine products must be avoided for at least 48 hours before each dose and during any clinic stay
• People who have taken part in another clinical drug trial within the past 90 days or more than 4 interventional trials in the past year; people who have had a medical device implanted within the past 90 days that might affect their ability to complete the trial
• People who have received a solid organ or bone marrow transplant
• People who have taken immune-suppressing, immune-modifying, or cytotoxic medicines within the past 6 months
• People who have taken blood-thinning or antiplatelet medicines (such as aspirin, warfarin, or similar) within 14 days before the first dose
• People who have received a live vaccine within 28 days before screening, or who plan to receive one within 28 days of the first dose (COVID-19 vaccines are not considered live vaccines)
• People who have been taking corticosteroids above a certain dose (equivalent to more than 5 mg per day of prednisone), or other immune-suppressing medicines, within 4 weeks before screening (topical, joint-injection, and inhaled steroids are generally allowed — confirm with trial site)
• People who have taken herbal medicines or supplements known to affect the liver within 3 months before screening, or who have started any new herbal medicine or supplement within 30 days before the first dose
• People who are pregnant, planning to become pregnant during the trial, or currently breastfeeding
• People who, for any other reason, the trial doctor considers unsuitable for participation

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