This Phase I study is in support of the development of NVC-422 as a product candidate to treat or prevent catheter associated urinary tract infections. In this trial, designed to evaluate the safety of a prototype NVC-422 solution in the bladder, there were no serious adverse events and the number and nature of adverse events collected was not significantly different between the treated groups and those on placebo.
The study involved two Phases. In the first Phase, cohorts of catheterized volunteers were given single doses of escalating concentrations of NVC-422 until the maximum planned dose was reached. In the second Phase, catheterized volunteers participated in a double-blind placebo controlled one week study where they were administered the highest planned concentration of NVC-422 once daily. This study was designed to evaluate the safety and tolerability of NVC-422 in the bladder.
Behzad Khosrovi, NovaBay’s vice-president of R&D, said: “We were very pleased to see that NVC-422 was tolerated in the human bladder at the highest dose planned. It is well known that the bladder is more sensitive than most organs to many small molecules, so with these positive results, we are now able to plan our Phase II clinical program which is likely to involve several exploratory studies that are designed to enable us to optimize the regimen for the product.”