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:

Part A – Healthy Volunteers (single dose portion of the trial):

• Adults aged 18 to 55 who are generally in good health
• People who meet minimum weight requirements (at least 50 kg for men, at least 45 kg for women) and whose body weight falls within a healthy range relative to their height (BMI between 18 and 35)
• Women who could become pregnant must agree to abstain from sex or use an effective form of birth control during the study
• Men must either have had a surgical procedure that prevents them from fathering children, or agree to use effective birth control during the study
• People who are willing and able to understand what the study involves, including potential risks, follow all study requirements, and sign a written consent form

Part B – People with Rheumatoid Arthritis (multiple dose portion of the trial):

• Adults aged 18 to 70 whose body weight falls within an accepted range relative to their height (BMI between 18 and 40)
• People who have been diagnosed with rheumatoid arthritis (RA) for at least 3 months before the screening visit, meeting recognised international classification criteria for RA
• People who have been taking methotrexate (a common RA medication) at a dose of 7.5 to 25 mg per week for at least 3 months, with the dose kept stable for at least 4 weeks before joining the study; certain other RA medications such as hydroxychloroquine, chloroquine, or sulfasalazine may also be permitted if started at least 3 months before joining and kept at a stable dose

Who may not be able to join:

Part A – Healthy Volunteers:

• People who have had surgery in the 4 weeks before screening, or who have surgery planned during the study period
• People who have taken prescription medicines, biological products, or other medications within 2 weeks before the first study day (or within a longer window depending on how long the medication stays in the body); people who have taken over-the-counter medicines or supplements within 7 days of dosing, unless the study doctor considers them unlikely to affect results
• People who have taken part in another clinical trial or received an experimental drug within 30 days (or longer, depending on the drug) before the first dose
• People with a significant abnormality detected on a heart tracing (ECG)
• People who test positive for HIV, active hepatitis C, or hepatitis B
• People who test positive for COVID-19
• People who test positive for tuberculosis (TB) based on specific blood tests
• People who have had a bacterial, viral, fungal, parasitic, or other serious infection within 30 days before the first study day
• People with a documented history of drug misuse in the past 12 months, or who test positive for drugs in a urine screen at screening or the day before dosing
• People who have donated blood or lost more than 400 mL of blood in the 3 months before screening, or who have received a blood transfusion within that same period
• People with a history of significant allergies, including allergies to protein-based medicines, rubber, or latex, or other allergies that the study doctor considers would make participation unsafe
• People who have smoked more than 10 cigarettes (or the equivalent) per day on average in the 6 months before screening
• People who drink more than 14 standard alcoholic drinks per week, or who return a positive alcohol breath test the day before dosing

Part B – People with Rheumatoid Arthritis:

• People who have an inflammatory joint condition other than RA (a current diagnosis of secondary Sjögren's Syndrome is an exception and may be permitted)
• People who have had surgery in the 4 weeks before screening, or who have surgery planned during the study period
• People with a history of any cancer in the past 5 years, except for certain successfully treated skin cancers or a localised, treated cervical condition
• People with a documented history of drug misuse in the past 12 months, or who test positive for non-prescribed drugs (other than cannabis/cannabinoids) in a urine screen at screening
• People who have any other condition that the study doctor considers would make participation in the study inappropriate
• People who have donated blood or lost more than 400 mL of blood in the month before screening, or who have received a blood transfusion within 3 months of screening
• People who, after their screening visit, use steroid medications at a dose above the equivalent of 10 mg per day of prednisone, or who increase their steroid dose
• People who test positive for HIV, active hepatitis C, or hepatitis B
• People who test positive for tuberculosis (TB)
• People who have had a bacterial, viral, fungal, parasitic, or serious opportunistic infection that had not fully resolved at least 14 days before the first study day, who may need antibiotic treatment during the study period, or who have a history of recurring infections
• Employees or close relatives of employees working at the study site, the company sponsoring the trial, or the research organisation running the trial

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