Phase 1 Hepatitis B Trial, Recruiting

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:

• You are a man or woman between 18 and 75 years old
• Your body mass index (a measure of body weight relative to height) is between 17.5 and 40.0, and you weigh more than 50 kg (110 lbs)
• If you are a woman who could become pregnant, you and any male partner who has not had a vasectomy must agree to use highly effective birth control during the trial

If you have normal kidney function, you must also:

• Be in good general health with no significant issues found during medical history review, vital signs, blood tests, or heart tracing (ECG)
• Match certain characteristics (such as age, weight, and where possible, sex) to other participants in the study
• Have normal kidney function, with no known or suspected kidney problems (confirm with trial site for specific test values)

If you have reduced kidney function, you must also:

• Have a kidney function test result that confirms a certain level of kidney impairment, taken within 28 days before receiving the study drug
• Have any form of kidney impairment, except for a current active condition called acute nephritic syndrome (a past history of this condition that is now in remission may still be acceptable)
• Have been on stable medications to manage your health conditions for at least 28 days before your screening visit
• Have a heart tracing (ECG) and vital signs that meet the study's requirements

Who may not be able to join:

• You have a current or past illness that the study doctor believes could affect the results or put you at additional risk
• You have a history of heart rhythm problems, certain risk factors for a specific heart condition called Torsade de Pointes (such as low potassium levels or a family history of long QT syndrome), or significant/unstable heart disease (confirm with trial site)
• You have a history of a serious allergic reaction to a medication
• You have used recreational drugs or have a history of drug misuse within the past year
• You regularly drink more than 14 units of alcohol per week (if you are a woman) or more than 21 units per week (if you are a man)
• You are unwilling to avoid alcohol for 48 hours before the study starts through to the end of the follow-up period
• You have Hepatitis A, B, C, or E, HIV, or a current active infection such as COVID-19
• Your liver enzyme levels (specific blood test results) are more than twice the normal upper limit (confirm with trial site)
• Your bilirubin levels (a substance measured in blood) are more than 1.5 times the normal upper limit, unless a harmless condition called Gilbert's syndrome is suspected
• You are pregnant or have a positive pregnancy test at enrolment

If you have normal kidney function, you may also not be able to join if:

• Your haemoglobin (a measure of red blood cells) is below 10 g/dL

If you have reduced kidney function, you may also not be able to join if:

• You are currently receiving haemodialysis or peritoneal dialysis (kidney filtering treatments)
• Your haemoglobin is below 9 g/dL

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