The first cohort in the two phase I clinical studies have completed treatment. OCT-Clinical Trials in Central and Eastern Europe has been conducting two phase I studies in healthy volunteers. The safety profile in the both projects has been confirmed. The Sponsor is a Russian company producing innovative peptide-based medications.
One investigational product is a drug, which aims to prevent and to treat various qualms, including chronic fatigue syndrome. This syndrome is a disorder caused by many factors. Disturbing factors (which could be infections, physical overexertion, stress, etc.) bring about dysfactions in the work of immune and endocrine systems as well as central nervous systems.
The other investigational product is a drug, which aims at addressing alcohol dependence. Usual treatment methods include several steps to be taken in order to avoid the disease progression. One measure is to decrease acute alcoholic disorder, and first of all – prevention or elimination of withdrawal syndrome and its complications, which include hangover convulsionary attacks, alcohol delirium. The other mean would be then anti-relapsing therapy.
In these both studies, OCT is cooperating with one of the leading institutions in the Russian Federation, which have the special accreditation for hospitalizing healthy volunteers, who take part in phase I and bioequivalence studies. The institute has vast experience in similar studies, equipped with all the necessary facilities, having professional team on staff to carefully conduct studies of this kind and scope.
The clinical trial with the drug against chronic fatigue will include a maximum of 33 subjects, who will complete the study. The other trial, with the medicine against alcohol addiction, aims at having a maximum of 24 subjects, who will complete the study. After the full successful completion of the development programme (phase II and III) for these medicinal products, the Sponsor plans to market the medications in the Russian Federation, these new medicaments to be available for patients with the aforementioned disorders.