OCT to obtain approval for a phase I clinical study

This is a double-blind, randomized, placebo-controlled multiple-dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug in healthy volunteers.

The primary objective of the study is to estimate the safety and tolerability of the drug in different dosage in comparison to the placebo. This study also provides for the assessment of frequency and severity of adverse events.

In this study, subjects will be divided into three dosage cohorts each consisting of six women aged from 18 to 40. The active treatment arm will be determined via randomization. Considering a possible dropout rate, it is expected to screen up to 80 healthy volunteers. 

The investigational drug was developed to treat idiopathic infertility in women, which is possibly etiologically associated with the central origin causes, including psychogenic factors. According to the latest data, the drug is shown to restore weak sexual and reproductive function.

As reported by the Ministry of Health of the Russian Federation, in 2010 there were about 1.6 million women who faced conception-related difficulties. Current female infertility treatment options include medical therapy, auxiliary medical services, interventional methods or their combinations. However, the rate of success for all these options amounts to 40-60% only. Another important medical problem associated with the central regulation of reproductive function is a female sexual dysfunction. There are currently no approved pharmacological options for this condition. Medical need for new effective and safe treatments for female infertility treatment remains critical.

In this clinical research project OCT team is responsible for the preparation and translation of CSP and ICF, safety monitoring plan, site selection, communication, negotiation- and administration-related activities, project management, regulatory and ethics management, pharmacovigilance, integrated study report, submission of final CSR to regulatory authorities, etc.