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 able to give written agreement to take part in the study
• Men and women between 18 and 60 years of age (inclusive)
• People who weigh at least 45 kg and have a body mass index (a measure of body weight relative to height) of 32 or below
• People who have been diagnosed with rheumatoid arthritis (RA) according to recognised medical classification criteria for at least 3 months before the screening visit
• People who have been taking a stable dose of methotrexate (a common RA medication) for at least 4 weeks before the study starts
• People who are able to follow the study requirements for its full duration, including staying at the study site for around 3 days
• People who have suitable veins for blood collection
• Women who are not pregnant and not breastfeeding, and who are either past childbearing age or have had a documented surgical procedure that prevents pregnancy — or, if pregnancy is possible, those willing to use a highly effective form of contraception throughout the study and who have a negative pregnancy test at screening (confirm with trial site for the full list of accepted contraception methods)
• Men who agree to avoid donating sperm and to use a condom during sexual activity with a woman who could become pregnant, from the start of the study drug until 90 days after the last dose, and who agree to encourage their partner to also use effective contraception
• People whose disease status the study doctor considers appropriate for this exploratory safety study

Who may not be able to join:

• People with abnormal results in their medical history or physical examination that the study doctor considers clinically important
• People with significantly abnormal results on screening blood or laboratory tests
• People with a known active infection with HIV, hepatitis B, tuberculosis, or hepatitis C
• People with clinically important abnormalities on a 12-lead heart tracing (ECG)
• People who have had an acute infectious illness within 2 weeks before the screening visit
• People who have, or have had, any autoimmune disease other than RA, a chronic inflammatory condition, or a significant allergic condition such as asthma, hives, eczema, or hay fever
• People with a significant history of kidney, liver, digestive, heart, lung, skin, blood, hormonal, inflammatory, chronic infectious, or neurological disease
• People with a history of a severe allergic reaction (anaphylaxis) to a medication, or other major allergic reactions that the study doctor considers a safety concern
• People who have had a cancer diagnosis in the 5 years before screening (except certain non-melanoma skin cancers)
• People with a history of any chronic inflammatory joint condition that began before the age of 18, or a history of acute joint inflammation caused by something other than RA
• People who are currently taking part in, or have recently taken part in, another clinical trial involving an experimental medicine or medical device (within 30 days before screening, or longer depending on the previous trial drug)
• People with a known allergy or sensitivity to the study drug or any of its ingredients
• People with a history of drug or alcohol misuse
• People taking certain medications that are not permitted in this study (confirm with trial site for the specific list)
• People who plan to have elective procedures or surgeries at any point after signing the consent form until the end of the study
• People who are employees of the company sponsoring the trial, or employees or family members of the study investigator
• People who are in an institution under a court or government order
• People who do not have the legal capacity to give informed consent

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