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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Administered by IV infusion
Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States
Incidence of Adverse Events (AEs) (Part 1)
Time frame: Up to Day 57
Incidence of Adverse Events (AEs) (Part 2)
Time frame: Up to Day 99
Number of participants with clinical laboratory abnormalities (Part 1)
Time frame: Up to Day 57
Number of participants with clinical laboratory abnormalities (Part 1)
Time frame: Up to Day 99
Number of participants with physical examination abnormalities (Part 1)
Time frame: Up to Day 57
Number of participants with physical examination abnormalities (Part 2)
Time frame: Up to Day 99
Number of participants with dose limiting toxicities (DLT) (Part 1)
Time frame: Up to Day 57
Number of participants with dose limiting toxicities (DLT) (Part 2)
Time frame: Up to Day 99
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