Safety and blood-level study of PBP1502 versus Humira
This Phase 1 study tests how a new medicine (PBP1502) behaves in the body and checks safety, comparing it to Humira. It is done in healthy adults to see dosing, side effects, and blood levels before moving to studies in patients.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be between 18 and 55 years old and generally healthy based on exams and blood/urine tests.
- Your body mass index (BMI) must be between 18.0 and 32.0.
- You must agree to use very effective birth control during the study and for 5 months after the dose (including sperm/donation rules for men).
- You must not have certain infections (including HIV, hepatitis B/C with active infection, and recent or serious fungal infections), tuberculosis, or recent serious illness.
- You must not have major ongoing medical conditions (such as significant heart, lung, liver, kidney, autoimmune diseases, diabetes, or blood disorders).
- You must not have had Humira (adalimumab) before, and must avoid certain medicines and vaccines in specific time windows.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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