XC8 Safety, Tolerability and Pharmacokinetics in Healthy Volunteers

Inclusion Criteria:

1. Non-smoking men aged 18 to 50 years (inclusive);
2. Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
3. Body mass index of 19 to 30 kg/m2 (inclusive);
4. Consent to use reliable methods of contraception during the study and 3 months after its completion (condoms with spermicide);
5. Signed patient information sheet and informed consent form for participation in the study.

Exclusion Criteria:

1. Hepatic disorder or renal disease; any other disease that, in the opinion investigator, may affect the results of the study, or may lead to the health aggravation during the study;
2. Laboratory abnormalities at screening;
3. Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;
4. Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test;
5. The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
6. Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening;
7. History of allergies (including medicines and food products);
8. Symptomatic rhinitis in anamnesis during 2 years prior to screening (allergic rhinitis, non-allergic rhinitis or pollinosis);
9. Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening;
10. Participation in other clinical trials or taking the study drug during 3 months before screening;
11. Impossibility to understand or follow protocol instructions;
12. Smoking 3 months before screening;
13. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
14. Acute infectious diseases less than 4 weeks before the start of the study.