26.Jan.2012

OCT received regulatory approval for two phase I trials in healthy volunteers

OCT have obtained two regulatory approvals for two phase I trials in healthy volunteers in Russia. The Sponsor is a new Russian biotechnology company with a portfolio of innovative drugs.

OCT have obtained two regulatory approvals for two phase I trials in healthy volunteers in Russia. The Sponsor is a new Russian biotechnology company with a portfolio of innovative drugs.

Each of the clinical trials will enroll volunteers in one phase I unit. Both clinical studies will be performed in groups of volunteers who will receive different doses of the IMP, starting from the lowest one. Possible adverse events will be closely monitored in each group after drug administration.

The first trial will be conducted for the medicinal product that is planned to be used as a treatment from chronic fatigue syndrome. There are different treatment schemes for patients suffering from the disease. The new product seems to be quite simple in terms of drug administration.

The second clinical study is planned with the newly developed drug that will in routine practice be used to treat chronic alcohol addiction.

The preceding pre-clinical studies of the products have expressed its effectiveness in animals. Supposedly, the results of the first-in-human studies for the two products will confirm its safety and effectiveness.
Qualification visits to the hospital have recently been performed in connection with the studies.