Phase 1 Rheumatoid Arthritis 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 male or female, aged 18 to 55 (for the healthy volunteer part) or 18 to 70 (for the rheumatoid arthritis patient part), at the time of screening.
• People with a body weight of at least 50 kg at screening.
• People whose body mass index (a measure of weight relative to height) falls between 18 and 32 (for healthy volunteers) or between 18 and 40 (for rheumatoid arthritis patients) at screening.
• Healthy volunteers for Part 1 of the study, or people diagnosed with rheumatoid arthritis for Part 2.
• Females who are not pregnant and not breastfeeding at screening.
• Females who are not able to become pregnant, either due to surgery, a natural physical condition, or being postmenopausal.
• Females who could become pregnant and whose male partner has not had a vasectomy must agree to use reliable contraception from at least 4 weeks before taking the study drug until 90 days after the last dose.
• Males who have not had a vasectomy must agree to use reliable contraception and not donate sperm from entry into the trial site until 90 days after the last dose.
• People who are willing and able to avoid all non-prescribed medicines, vitamins, supplements, and herbal products (such as St. John's Wort) for at least 7–14 days before taking the study drug (or longer depending on the product), unless the trial doctor decides it is safe to continue.
• People who are willing and able to avoid alcohol for at least 3 days before each visit to the trial site and until discharge.
• People in North America who are willing and able to avoid caffeine and caffeine-containing food and drinks (such as coffee, tea, cola, chocolate, and energy drinks) for at least 3 days before each visit and until discharge.
• People in the EU who are willing and able to avoid caffeine and caffeine-containing food and drinks for at least 2 days before each visit and until discharge.
• People who are in good physical and mental health, as assessed by the trial doctor through medical history, physical checks, blood and urine tests, heart tracings (ECG), and vital signs.
• People with blood pressure readings that the trial doctor considers to be within an acceptable range.
• People with heart tracing (ECG) results that the trial doctor considers to show no significant abnormalities.
• People with blood and urine test results that fall within normal ranges or show no significant concerns, as judged by the trial doctor.
• People who are willing and able to sign a consent form agreeing to participate.
• For rheumatoid arthritis patients (Part 2 only): People who have been taking methotrexate (by mouth or injection) at a dose of 5 to 25 mg once per week for at least 12 weeks before screening, with the dose stable for at least 4 weeks before screening and expected to remain stable throughout the study.
• For rheumatoid arthritis patients (Part 2 only): People with currently active rheumatoid arthritis, meaning at least 6 swollen and 6 tender joints, plus elevated inflammation markers in the blood (confirm with trial site).

Who may not be able to join:

• People who previously took part in a related earlier study (Study IA-14069_1a).
• People who are employees of ICON or the trial sponsor company.
• People who have taken part in another clinical trial or used an investigational drug or device within the past 30 days (or longer, depending on the drug).
• People with any medical condition that the trial doctor considers to pose an unacceptable health risk.
• Females who are pregnant, breastfeeding, or planning to try to become pregnant during the study or within 90 days after the last dose.
• Males whose female partners are pregnant, breastfeeding, or planning to try to become pregnant during the study or within 90 days after the last dose.
• People with a history of serious allergic or sensitivity reactions to drugs or foods (such as severe allergic reactions requiring emergency treatment), as determined by the trial doctor.
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People who have used tobacco or nicotine products within 60 days before taking the study drug (for healthy volunteers in Part 1 only).
• People with a history, in the past 12 months, of regularly drinking more than 2 standard alcoholic drinks per day on average.
• People who test positive for drugs of abuse (including opiates, cocaine, amphetamines, cannabis, and others) or alcohol at screening or on arrival at the trial site; also includes a positive cotinine (nicotine) test for Part 1 participants.
• People who test positive for hepatitis B, hepatitis C, or HIV at screening.
• People who have donated or lost more than 450 mL of blood in the 60 days before taking the study drug, or who plan to donate blood within 30 days after the last dose.
• People who have donated plasma or platelets within 7 days before taking the study drug.
• People who have had a significant or sudden illness within 5 days before taking the study drug that may affect safety results, in the trial doctor's opinion.
• People whose veins are not suitable for taking blood samples.
• People who regularly use prescription or non-prescription medicines, vitamins, or supplements within 7–14 days (or longer, depending on the product) before the first dose — exceptions may apply for certain medicines in the rheumatoid arthritis group and will be assessed case by case by the trial doctor.
• Rheumatoid arthritis patients (Part 2 only) who are currently taking, or have recently taken, a biologic DMARD (a type of medicine that targets the immune system) within 6 weeks or 5 half-lives before screening.
• Rheumatoid arthritis patients (Part 2 only) who are currently taking, or have recently taken, a targeted synthetic DMARD (including apremilast, baricitinib, filgotinib, or tofacitinib) within 6 weeks or 5 half-lives before screening.
• Rheumatoid arthritis patients (Part 2 only) who are currently taking, or have recently taken, any other conventional synthetic DMARD (other than methotrexate) within 6 weeks or 5 half-lives before screening.
• People who have done strenuous exercise, sunbathing, or contact sports within 2 days before arriving at the trial site through to the follow-up visit.
• People who have eaten or drunk anything known to affect how the body processes certain medicines — such as grapefruit, pomelo, star fruit, or Seville orange products — within 14 days before taking the study drug or during the study.
• People the trial doctor considers unable to follow the safety monitoring requirements of the study or otherwise unsuitable for participation.
• People who have received a COVID-19 vaccine or any other vaccine within 7 days before taking the study drug.
• Healthy volunteers (Part 1 only) with significant liver function abnormalities, as judged by the trial doctor based on blood test results at screening and the day before dosing.
• Healthy volunteers (Part 1 only) with significant kidney function problems, based on a specific kidney function calculation and urine protein results, as judged by the trial doctor at screening and the day before dosing.
• Rheumatoid arthritis patients (Part 2 only) with certain liver-related blood test results that are significantly above normal levels at screening and the day before dosing (confirm with trial site for specific thresholds).
• Rheumatoid arthritis patients (Part 2 only) with a kidney function score below a certain threshold, based on a standard kidney function calculation, at screening and the day before dosing (confirm with trial site).

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