Date: 2015-05-25
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: R-Tech Ueno (Japan)
Product: RTU-1096
Action
mechanism: protein inhibitor/VAP-1 inhibitor. RTU-1096 is a vascular adhesion protein-1 (VAP-1) inhibitor having anti-inflammatory and immunomodulatory effects.
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country:
Trial details:
Latest
news: * On May 25, 2015, R-Tech Ueno announced that the phase I single-dose clinical trial for the new molecular entity RTU-1096 has been completed. This trial intended to examine the safety, tolerability, and pharmacokinetics of RTU-1096 in a single dose. It was conducted as a placebo-controlled double-blind study, and investigational drugs were administered to 40 subjects in total. All subjects completed the full administration period without any cases of discontinuation. Five adverse events in five subjects, including the placebo group, were reported, however, none of them were regarded as causally related to the investigational drug, nor determined as the side effect. Accordingly, safety and tolerability of RTU-1096 up to the highest dose have been confirmed. Furthermore, serum VAP-1 activity of each subject was measured in this trial, and the result showed significant reduction in serum VAP-1 activity of all subjects, from low-dose group to high-dose group, immediately after the administration of RTU-1096. Its effect lasted longer, and the reduced serum VAP-1 activity has recovered gradually. Based on these results, R-Tech Ueno will proceed to the repeated dose clinical trial of RTU-1096 as scheduled. The preparation of this trial has been initiated. This repeated dose trial will also evaluate safety, tolerability, pharmacokinetics, and the effect on serum VAP-1 activity of RTU-1096.
