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news.Japan-based pharmaceutical venture business R-Tech Ueno has completed the Phase I single-dose clinical trial for the new molecular entity RTU-1096, a vascular adhesion protein-1 (VAP-1) inhibitor having anti-inflammatory and immunomodulatory effects.
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The single-dose study is the first stage of the Phase I trial, which the company is currently carrying out for the oral agent of a new molecular entity (RTU-1096), which is targeted at healthy adult males.
The company is developing an anti-inflammatory drug with a new mechanism of action based on VAP-1 inhibitory effect.
The single-dose trial was designed to examine the safety, tolerability, and pharmacokinetics of RTU-1096 in a single dose.
A total of 40 subjects were administered with investigational drugs in this placebo-controlled double-blind trial.
The company said that all subjects completed the full administration period without any cases of discontinuation.
In the trial, 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.
Safety and tolerability of RTU-1096 up to the highest dose have been confirmed in the trial.
In addition, 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.
R-Tech Ueno president Yukihiko Mashima said: "This VAP-1 inhibitor RTU-1096 is an agent that is First in Class (First-in-Human use).
"We are very pleased that the trial result confirmed the safety of RTU-1096 up to the highest dose. In addition, the trial data indicated significant and sustained reduction in serum VAP-1 activity after once-daily low-dose administration of RTU-1096.
"This data is also quite useful for our future clinical development. Going forward, we will carry out the repeated dose trial of RTU-1096 to further evaluate its safety and to determine its appropriate dosing regimen in Phase II study."
Based on these results, the company has decided to proceed to the repeated dose clinical trial of RTU-1096 as scheduled, and have started the preparation of this trial.
Image: R-Tech Ueno is conducting the trial for the oral agent of a new molecular entity (RTU-1096) targeting healthy adult males. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.