Safety, tolerability and pharmacokinetics of PL 14736, a novel agent for treatment of ulcerative colitis, in healthy male volunteers.

PL 14736, a novel 15 amino acid peptide, has shown benefical activity in experimental models of gastrointestinal damage. Seven-day intracolonic administration of PL 14736 to rats has significantly reduced the extent TNBS-induced colonic damage and hastened healing. These results have encuraged the development of the compound for the treatment of patients with ulcerative colitis. In this first study in man, rectal administration of PL 14736 to healthy male volunteers was safe and well tolerated. Based on these data, a randomized, double-blind, placebo-controlled study was started in order to investigate the tolerabillity and efficacy of Pl 14736 enemas in patients with acute mild to moderate ulcerative colitis