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 aged 18 to 55 years, with at least 3 participants of each gender required per group
• People with a BMI between 18 and 30, and a body weight of at least 50 kg for men or at least 45 kg for women
• People with no significant health problems found during medical history review, physical examination, vital signs check, blood tests, heart tracing (ECG), or lung imaging
• People who are willing and able to use effective contraception throughout the study, with no plans to conceive during that time; women who could become pregnant must have a negative pregnancy test and must not be breastfeeding; women who cannot become pregnant must have had a hysterectomy, removal of the fallopian tubes, or be postmenopausal (confirmed by hormone levels)
• People who are able to give informed consent and are willing to follow all study requirements

Who may not be able to join:

• People with a known allergy to the study drug (GenSci120) or a history of severe allergic reactions
• People with skin or tissue problems at potential injection sites that could affect assessment
• People with significant medical conditions that could affect study results
• People with a history of cancer or malignant tumours, including specific cancers listed by the trial (confirm with trial site)
• People with a history of seizures or a head injury that caused loss of consciousness
• People with a psychiatric condition that affects daily functioning or with significant cognitive difficulties
• People with severe immune system deficiencies, such as HIV
• People who have recently experienced serious physical trauma, undergone surgery, or have digestive conditions that could affect how the body absorbs substances
• People who have had a severe infection recently or have recently received antibiotic or antimicrobial treatment
• People who received a live vaccine within one month before the screening visit
• People with abnormal vital signs or heart tracing results, including very high or very low blood pressure, or a specific heart rhythm measurement (QTcF) above 450 milliseconds
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis at screening
• People who test positive for tuberculosis (TB) via an IGRA blood test
• People who have recently used immunosuppressive medications or targeted therapies
• People who have taken any medication within 14 days before being assigned to a study group
• People who are currently participating in, or have recently participated in, another clinical trial
• People with a history of excessive alcohol consumption over the past six months
• People who are heavy smokers, are unwilling to stop smoking during the trial, or test positive for nicotine
• People who test positive on a drug screening test for specified substances
• People who have used recreational or other specified drugs within defined time periods before the trial (confirm specific timeframes with trial site)
• People who have recently donated blood, received blood products, or have poor vein access for blood draws
• People who are employed as staff on this trial
• People who investigators consider unsuitable for the trial for any other reason

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