Rheumatoid Arthritis (RA) is a long-term inflammatory disease that causes pain, swelling,
stiffness and loss of function in joints, with an approximately 0.5 to 1% (and increasing) prevalence in adults worldwide. Alongside many treatment options, there’s recently been an increased focus on producing biosimilars, with many new drugs expected to come to the market in the coming years [1].
The primary aims of Phase 1 clinical trials are to determine the safety, tolerability and pharmacokinetics (PK) of a compound. Trials have historically been conducted in the logical sequence of single ascending dose, multiple ascending dose, examination of preliminary effect of food on exposure, and potential drug drug interaction, with assessments to determine the effect of gender, age, bioavailability and bioequivalence performed as necessary.
