Phase I study of Tomaralimab (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 Tomaralimab (OPN-305) in healthy subjects. It was performed at study site at PRA International, Clinical Research Unit, University Medical Centre Groningen, The Netherlands.

Overall, Tomaralimab (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.