This randomized, double-blind, placebo-controlled Phase I/II study will consist of two sequential stages, Stage A and B. This protocol describes the objectives, design, and procedures for Stage A of the study. The protocol will be amended in future when sufficient data from Stage A have been collected to initiate Stage B. The protocol amendment will describe the objectives, design, and procedures for Stage B of the study.~Stage A will be a randomized, double-blind, placebo-controlled, multi-dose, sequential dose escalation sub-study in 24 subjects with stable RA. Three sequential dose cohorts of 8 subjects will be included in this stage:~Cohort 1: 100 mg CCX354-C or placebo~Cohort 2: 100 mg CCX354-C or placebo~Cohort 3: 200 mg CCX354-C or placebo~Safety and PK data from each cohort will be reviewed by a data monitoring committee (DMC)before dose escalation to the next dose level. The study will proceed to Stage B only if the safety and tolerability profile of Stage A is deemed acceptable by the DMC.
The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of CCX354-C at a number of dose levels in subjects with stable rheumatoid arthritis (RA).