OCT is proud to announce that we have completed Phase I for both of these clinical projects in November. Both of these trials were an open label, single center, clinical studies to evaluate the safety and tolerability in healthy volunteers in Russia.
There were no serious adverse effects that occurred during the Phase I of this trial in either of the populations of the healthy volunteers. Based on this number of no recorded SAEs it can be concluded that there was good tolerability of these new compounds. The final study report is currently being prepared. OCT is currently in the submission process to the Regulatory Authority (RA) for the Phase II/III for both of these clinical trials. Both trials are randomized, multicenter, double-blind, and placebo controlled testing the efficacy and safety of the study drug in subjects with alcoholic disorder and anxious adjustment disorder. These are two separate trials, but the design for the Phase I was the same and they actually shared the same sites in that first trial.
OCT has designed an adaptive design for the Alcoholic disorder study, which will have 72 randomized patients into 4 groups, 2 different doses of the study drug, along with 2 placebo groups. When the first 72 patients complete the study an interim analysis will be performed to define a more effective dosage if necessary. Based on the interim analysis results, one dose is chosen and 48 patients will be included into stage 2 of the trial. The total number of patients in this clinical trial will be 120 spread out through 6 investigational sites in Russia. The duration of the study should last about 2 years. The clinical study regarding the anxious adjustment disorder has a total of 231 screened patients, with 196 randomized throughout 12 investigational sites in Russia. Half of these sites are located in St. Petersburg and the rest spread around the country. This trial also has a duration period of 2 years.
OCT is very excited for both of these upcoming trials in the near future. OCT will be providing our full-service spectrum of clinical services for this Sponsor. This means we are responsible for the trial conuctfrom the submission to the Regulatory Authorities through recruitment and the trial itself and using our EDC and closing the sites. Both of these disorders are a global problem, and OCT is pleased to help bring new medications to the market which will provide treatment for those who suffer from alcoholic disorder and anxiety.