XC8 Safety, Tolerability and Pharmacokinetics in Healthy Volunteers

One Russian center was approved for participation in this study. One center was initiated. Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single administration, multiple administration and follow-up.

All eligible subjects were randomized into the study in appropriate cohort groups sequentially.

Cohort 1 - XC8 or Placebo 2 mg once and then daily 14 days after a 6-day break; Cohort 2 - XC8 or Placebo 10 mg once and then daily during 14 days after a 6-day break; Cohort 3 - XC8 or Placebo 50 mg once and then daily during 14 days after a 6-day break; Cohort 4 - XC8 or Placebo 200 mg once and then daily during 14 days after a 6-day break.

The decision regarding increasing of the study drug dose for a subsequent cohort was made by the Data Safety Monitoring Committee on the basis of preliminary safety results assessment.

A total of 20 volunteers received XC8 (2 mg, 10 mg, 50 mg or 200 mg) and a total of 8 volunteers received the placebo during the study participation. The follow-up period lasted for 4 weeks.

Inclusion criteria

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

Exclusion criteria

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