This is a local study initiated by a well-known Russian biotechnological company that has been working with OCT for a number of projects during the past several years.
The main objective of this open phase I study is to investigate the safety and acceptability of the investigational drug in healthy volunteers. Another goal is to access the pharmacokinetics and pharmacodynamics parameters of the drug.
The current study will be conducted in a cohort design with 3 consequent dose cohorts and multiple-dose introduction. The primary end-point with regards to the acceptability of the investigational drug will be the events of dose-limiting toxicity.
The investigational product is a peptide in the formulation of metered-dosed nasal spray, developed for the treatment of idiopathic female infertility etiologically associated with psychogenic factors.
In addition to that, the results of the pre-clinical studies demonstrated potential positive impact of the investigational product on the female sexual function.
Last years’ statistics proves the importance of development of such a product: according to the Ministry of Healthcare of the Russian Federation, about 1.6 million of Russian women have problem with conception of a child.
In 2010, the number of futile couples around the world was estimated at 48.5 million.
According to the US data, up to 20-26% of all the cases of infertility have no explanation (idiopathic infertility).
Administration of all the known types of treatment shows positive results only in 40-60% of cases, however, all of the used therapeutic approaches have certain risks with regards to safety, such as hormonal disorders, violation of hemostasis and surgery risks [Mascarenhas, M.N., Flaxman, S.R., Boerma, T., Vanderpoel, S., Stevens, G.A. (2012). "National, Regional, and Global Trends in Infertility Prevalence Since 1990: A Systematic Analysis of 277 Health Surveys "PLOS Med (9;12)].
Another serious medical problem is violation of sexual function in females. Today no medicinal product for pharmacological treatment of this problem is registered in any country of the world, while those medicinal products that are currently under development, have not demonstrated significant efficiency in the already conducted clinical trials, but have shown safety problems.
Development of the investigational product can help satisfy both of the described unmet medical needs.
OCT was involved in the project from the very beginning to prepare the Study Essential Documents and collect the Registration Dossier which will be submitted to the MoH in order to obtain the approval for the study conduct. After the phase I and II trials are finished and the sufficient results are obtained and added to the Dossier, OCT will help the Sponsor get marketing authorization of their drug.