Phase 1 Rheumatoid Arthritis 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:

• People who are generally healthy men or women between 18 and 45 years old (inclusive).
• Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (BMI) between 19.0 and 26.0 (a measure of weight relative to height).
• People who are able to communicate clearly with the research team, understand what the study involves, and are willing to follow all study procedures and attend all required visits, including signing a consent form before any study activities begin.
• People who have no plans to conceive a child or donate eggs or sperm from the time of signing the consent form until 6 months after the study ends, and who agree to use reliable contraception throughout that period.

Who may not be able to join:

• People who have or have had any significant medical condition, including problems affecting the lungs (such as tuberculosis), heart, digestive system, urinary system, muscles or joints, hormonal system (such as adrenal gland problems), nervous system or mental health (such as epilepsy), blood (such as G6PD deficiency or a condition called paroxysmal nocturnal haemoglobinuria), immune system, or those with known significant bleeding tendencies.
• People who have had a fever or infectious illness within 3 days before the screening visit.
• People with a history of stomach, liver, or kidney disease, including those who have had part of any of these organs surgically removed.
• People who have had a serious infection, significant injury, or surgery within 12 weeks before screening, or who have surgery planned during the study that the investigator considers a concern.
• People who have had a significant short-term illness (such as a stomach upset or infection) within 4 weeks before screening.
• People who experience ongoing or recurring pain lasting more than 3 months, or who are currently experiencing pain that has lasted less than 3 months.
• People with a history of significant allergies, including known reactions to the study drug or its ingredients, food allergies, pollen allergies, or other allergic conditions.
• People who have smoked more than 5 cigarettes a day (or an equivalent amount of tobacco) in the 3 months before screening, or who are unable to avoid tobacco use during the study.
• People who have a history of alcohol misuse, or who have been drinking an average of 14 or more units of alcohol per week in the 3 months before screening (for example, 14 small glasses of wine or 14 standard strength beers per week), who test positive for alcohol at the time of admission, or who are unable to avoid alcohol during the study.
• People who have been drinking more than 8 cups (250 mL each) of tea, coffee, or other caffeinated drinks per day on average in the 3 months before screening.
• People who are unable to avoid caffeine-containing foods or drinks (such as coffee, strong tea, cola, or chocolate) in the 72 hours before admission or during the study, or who consume foods known to affect how drugs are processed by the body, including dragon fruit, mango, grapefruit, pomelo, orange, starfruit, and guava.
• People who have taken part in another clinical trial involving a drug or medical device within 3 months before screening, or who have used an investigational (trial) product before their first study visit.
• People who have received a vaccination (such as COVID-19, tetanus, rabies, or HPV) within 2 months before screening.
• People who have donated blood or lost a significant amount of blood (400 mL or more) within 3 months before screening, received a blood transfusion or blood products within 3 months before screening, lost 200 mL or more of blood within 30 days before screening, or donated plasma within 7 days before screening.
• People who have used any prescription medicines, over-the-counter medicines, herbal products, or dietary supplements within 14 days before screening or between screening and their first study visit.
• People who have a history of fainting related to needles or the sight of blood, difficulty having blood taken, or a history of feeling faint when standing up (orthostatic hypotension).
• People who have special dietary needs that would prevent them from following the standardised meals provided during the study.
• People with a history of substance misuse or drug addiction, or who test positive for substances such as methamphetamine, MDMA, cannabis, morphine, or ketamine on the day of admission.
• Women who are pregnant or breastfeeding, or women of childbearing potential who test positive on a pregnancy test.
• People whose vital signs (such as blood pressure or heart rate), physical examination results, blood or urine test results, heart tracing (ECG), CT scan, or ultrasound results are considered abnormal by the investigator.
• Women who have used oral contraceptive pills within 30 days before screening or during the study, or who have used long-acting hormonal injections or implants (containing oestrogen or progestin) within 6 months before screening or during the study.
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis.
• People whom the investigator considers unsuitable for the study for any other reason.

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