Protagonist Therapeutics, Inc. announced that the company has initiated treatment of subjects with its lead drug candidate, PTG-100, in a Phase 1 clinical study. Protagonist is developing PTG-100, an orally-stable alpha-4-beta-7 integrin-specific peptide antagonist, as a potential treatment for patients with inflammatory bowel disease (IBD). The Phase 1 study, which is being conducted in Australia, is a randomized, double-blind, placebo-controlled, dose-escalation trial in 70 normal healthy volunteers.

The first part of the study consists of single-ascending doses of PTG-100 in 40 volunteers. The second part of the study will involve the administration of PTG-100 over 14 consecutive days in 30 additional volunteers. Primary endpoints for the study are safety and tolerability of PTG-100.

Secondary endpoints are the identification of the maximally tolerated dose and evaluation of pharmacokinetic and pharmacodynamic parameters.