Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8

Inclusion criteria

• Men and women aged 18 to 50 years;
• Generally good health;
• Body mass index of 19 to 30 kg/m² and >50 kg body weight;
• Female subjects who are post-menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practice a highly effective method of birth control, i.e. resulting in a failure rate of less than 1% per year when used consistently and correctly (e.g. implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence, or vasectomized partner). The birth control method must have been applied for at least 1 cycle before and until 3 months after administration of the study medication.
• Male subjects with a female partner of child-bearing potential agree to use a medically acceptable method of contraception (e.g. condoms, sexual abstinence, vasectomy) during the study, and until 3 months after the last intake of study medication.
• Subjects are willing and able (in the opinion of the investigator) to understand and comply with the procedures and evaluations of the study.
• Subjects must be willing and legally able to give written informed consent.

Exclusion criteria

• Hepatic or renal disease; any other disease, which may influence the clinical trial results or may lead to health worsening during the trial (according to the investigator's opinion);
• Clinically significant laboratory abnormalities;
• Use of any medication, including prophylaxis, within 1 month before screening (including herbal preparations and nutritional supplements);
• Positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus HBV at Screening;
• Irregular sleep (e.g. night work, sleep disturbances, insomnia, returning from another time zone, etc.);
• History or current evidence of alcohol or drug abuse; alcohol or drug intake within 4 days before Screening;
• History or current evidence of allergic reactions (including reactions to medications and food);
• History or current evidence of symptomatic rhinitis within 2 years before Screening (allergic rhinitis, non-allergic rhinitis, or hay fever, excluding short-term viral infection - cold or influenza);
• Blood or plasma donation, or surgery (in hospital) within 12 weeks of Screening;
• Lactating or pregnant females; a positive pregnancy test before the first administration of investigational medicinal product or breastfeeding;
• Current or previous (within 3 months of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study;
• Previous enrollment in this clinical study;
• Inability to understand or follow protocol instructions;
• Smoking within 3 months before screening or throughout the study;
• Lactose intolerance;
• History of allergic reactions to XC-8 or any inactive ingredients of the trial medication;
• Employees of the sponsor or subjects who are employees or relatives of the investigator;