Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169

Inclusion Criteria

• Written informed consent from the volunteer.
• Men and women aged 18-45 years, inclusive.
• Body mass index of 18.5-30 kg/m2.
• Verified "healthy" diagnosis based on physical examination, vital signs, standard laboratory tests (complete blood count and biochemical blood test, urine analysis) and instrumental tests (ECG, fluorography examination or X-ray examination).
• Negative results of tests for human immunodeficiency virus (HIV), syphilis, hepatitis B (Hbs Ag) and hepatitis C (antibodies to HCV).
• Ability to comply with all the requirements of the protocol in the opinion of the investigator.
• Consent of the participant and his/her partner to use reliable contraceptive methods during the study and within 90 days after the end of their participation. A reliable method of contraception is a combination of a male condom with at least one of the following methods:
• hormonal contraceptives used by the male's partner (only if she does not participate in this clinical study);
• use of aerosols, creams, suppositories and other agents containing spermicides;
• use of intrauterine device by female partner.

Exclusion Criteria

• History of allergies, including at least one episode of allergy to medications.
• Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, ENT, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, skin.
• Hypolactasia (lactose intolerance, lactase deficiency) or glucose-galatose malabsorption in medical history.
• Chronic eye diseases except for myopia, hypermetropia and astigmatism of mild and moderate severity.
• Surgeries on the gastrointestinal tract (except for appendectomy done more than 1 year before screening).
• Regular administration or use (including externally) of hormonal agent for more than 1 week less than 45 days before screening
• Regular administration of medicinal products less than 4 weeks before screening.
• Use of medicinal products that have a pronounced effect on liver function or hemodynamics (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before screening.
• Positive test for narcotics and psychotropic products.
• Blood pressure after resting in supine position for at least 5 minutes above 130 mm Hg (systolic blood pressure) and 90 mm Hg (diastolic blood pressure) or below 110 mm Hg (systolic blood pressure) and 60 mm Hg (diastolic blood pressure).
• Heart rate (according to ECG) after resting in supine position for at least 5 minutes above 90 bpm or below 60 bpm.
• Blood donation (450 mL of blood or plasma and more) less than 3 months before the screening.
• Acute infectious diseases less than 4 weeks before screening.
• Administration of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine or 50 mL of a spirit) or history of alcoholism, drug abuse, substance abuse.
• Mental diseases.
• Smoking for three months before screening.
• Participation in any clinical study less than 3 months before screening.
• Planned conception or sperm donation during the study after the administration of the investigational product or within 3 months after the last administration of the product.
• Positive pregnancy test for women.
• Breastfeeding period.