Phase 1 Non-Alcoholic Fatty Liver Disease 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:

• People who are willing to follow the study procedures, participate voluntarily, and sign a consent form agreeing to take part.
• People aged between 18 and 45 years old (inclusive) at the time of signing the consent form — both males and females are eligible.
• Male participants who weigh at least 50 kg, and female participants who weigh at least 45 kg, with a body mass index (a measure of body weight relative to height) between 18.0 and 28.0 for the single-dose part of the trial, or between 18.0 and 30.0 for the multiple-dose part.
• People joining the multiple-ascending-dose part of the trial must also have a specific blood cholesterol level (LDL-C) falling within the range of 2.6 to less than 4.1 mmol/L (confirm with trial site).
• People whose general health checks — including vital signs, physical examination, blood tests, heart tracing (ECG), chest X-ray, and abdominal ultrasound — are normal or show nothing considered medically significant by the study doctor.
• People who are willing to use effective contraception from the screening stage until 3 months after the last dose, and who have no plans to donate sperm or eggs during that time (this applies to participants and their partners).

Who may not be able to join:

• People who have had a significant medical condition before screening, including but not limited to conditions affecting the stomach or bowels, kidneys, liver, nervous system, blood, hormones, lungs, immune system, mental health, heart, or blood vessels.
• People who have a tendency to be allergic to multiple medicines or foods.
• People who smoked more than 5 cigarettes a day on average in the 3 months before screening, smoked within 48 hours before taking the study medication, or who would be unable to avoid all tobacco products during the trial.
• People who have had difficulty swallowing, or a history of stomach, bowel, liver, or kidney conditions or surgeries that could affect how the study drug moves through the body (except straightforward appendix removal or hernia repair).
• People with a history of heavy alcohol use within the past year (more than 14 units per week, where 1 unit equals approximately 285 mL of beer, 25 mL of spirits, or 100 mL of wine), or who test positive for alcohol at screening.
• People with a history of drug misuse or who have used recreational drugs within the 2 years before screening, or who test positive on a urine drug screen at screening.
• People who have donated blood or lost 400 mL or more of blood in the 3 months before screening, or who plan to donate blood within 1 month after the trial ends.
• People with a history of thyroid disease, or whose thyroid hormone levels (TSH) fall outside the normal range at screening.
• People whose heart electrical activity measurement (a specific interval on the ECG called QTcF) is greater than 450 milliseconds at screening.
• People whose kidneys are not filtering at a sufficient rate, based on a standard calculation from blood test results (confirm with trial site).
• People who received a vaccine in the month before screening, or who plan to receive a vaccine during the trial.
• People who took certain medicines known to affect how the body processes drugs (specific enzyme inhibitors or inducers, including those affecting CYP3A4, CYP2C8, P-gp, or BCRP) within 4 weeks before screening (confirm with trial site).
• People who took any prescription medicines, over-the-counter medicines, vitamin supplements, or herbal medicines within 14 days before screening.
• People who consumed foods or drinks containing chocolate, caffeine, alcohol, or grapefruit within 48 hours before the first dose.
• People who developed an illness or needed to take any medication between the screening visit and the first dose.
• People who faint at the sight of needles or blood, cannot tolerate having blood drawn via a needle, or whose veins make blood collection very difficult.
• Women who are pregnant, breastfeeding, or who test positive on a pregnancy test at screening.
• People who took part in another clinical trial within 3 months before screening (people who were screened for another trial but never received any treatment in that trial may still be considered eligible — confirm with trial site).
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis.
• People who have specific dietary needs that would prevent them from following the standard meals provided during the trial.
• People whom the study doctor considers unsuitable for the trial for any other reason.

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