Status and phase
Conditions
Treatments
About
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).
Full description
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:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal