Phase I study of OPN-305 complete
The study was a single centre, prospective, randomised, double-blind, placebo controlled, sequential, dose-escalating Phase I study to assess the safety and tolerability of intravenously infused single doses of OPN-305 in healthy subjects. It was performed at study site at PRA International, Clinical Research Unit, University Medical Centre Groningen, The Netherlands.
Overall, OPN-305 was well tolerated with no safety concerns for use in human patients.
Results from the Phase I study have been published: Randomized, double-blind, placebo-controlled, dose-escalating phase I, healthy subjects study of intravenous OPN-305, a humanized anti-TLR2 antibody. Reilly M, et al., Clin Pharmacol Ther. 2013 Nov; 94(5):593-600.