Evaluating a Drug
“A Placebo-controlled Study to Evaluate the Safety, Movement Through, and Reaction of the Body to Single and Multiple Increasing Doses of FB704A”
The cause of Rheumatoid Arthritis (RA) is not fully understood. However, one of the substances secreted by certain cells in the body, interleukin-6 (IL-6), is believed to play a major role in chronic inflammation that is typical in RA. This study investigates the drug FB704A, which is believed to lower the inflammation caused by IL-6. This study will be in 2 sequential parts: a single increasing dose part (Part 1) and a multiple-increasing dose part (Part 2). Subjects will receive either active or placebo drug by IV infusion. Subjects in both parts will have a short stay in the clinic at the start of the study, then will return for outpatient visits.
Drug - FB704A
Administered by IV infusion
Drug - Placebo
Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion
A Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704A