Bio venture firm R-Tech Ueno has completed the Phase I single-dose clinical trial for the new molecular entity RTU-1096.
RTU-1096 is a vascular adhesion protein-1 (VAP-1) inhibitor with anti-inflammatory and immunomodulatory effects.
R-Tech Ueno president Dr 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."
The company is involved in developing an anti-inflammatory drug with a new mechanism of action based on VAP-1 inhibitory effect.
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Currently, the firm is carrying out the Phase I clinical trial for the oral agent of a new molecular entity RTU-1096 that is targeted at healthy adult males.
R-Tech completed the single-dose trial, which is the first trial stage. It is designed to evaluate the safety, tolerability and pharmacokinetics of RTU-1096 in a single dose.
The trial has been carried out as a placebo-controlled double-blind study, in which investigational drugs were administered to 40 subjects in total.
According to the company, all subjects completed the full administration period without any cases of discontinuation and five adverse events in five subjects, including the placebo group, were reported.
The safety and tolerability of RTU-1096 up to the highest dose have been confirmed and serum VAP-1 activity of each subject was measured in this trial.
The result demonstrated 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 has decided to proceed to the repeated dose clinical trial of RTU-1096 as scheduled, based on these trials. The repeated dose trial will also assess safety, tolerability, pharmacokinetics, and the effect on serum VAP-1 activity of RTU-1096.