In the phase I trial, approximately 70 healthy volunteers will be randomized to receive orally-administered CRA-028129 or placebo. The dose amount and number of days of dosing will be escalated in sequential cohorts of study subjects in order to characterize the pharmacokinetic and maximum pharmacodynamic effects of CRA-028129.
This is a single center study being conducted at the Christchurch Clinical Studies Trust in New Zealand. The initiation of this study follows approval from the New Zealand director general of health on the recommendation of the Standing Committee on Therapeutic Trials (SCOTT).
“We’re pleased with the progress we’ve made in advancing our cathepsin S inhibitor through to this clinical development stage as a potential new treatment for psoriasis,” said Dr Robert Booth, chief scientific officer of Celera Genomics. “Through our preclinical research we have identified two biomarkers of cathepsin S inhibition that we will use during our clinical trials as indicators of the pharmacodynamic behavior of this compound.”