A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects

Exclusion Criteria

• •1. Mental illness or other conditions that may, in the Investigator's opinion, affect the subject's ability to comply with the Study Protocol.
• •2. Any significant, in the Investigator's opinion, surgical procedures performed less than 30 days before the screening examination and potentially affecting clinical study results.
• •3. A history of allergic reactions (anaphylactic shock or multiple drug allergy according to the Investigator's assessment).
• •4. Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the IP.
• •5. Impossibility of installing a venous catheter for collecting blood samples (e.g., due to skin disorders at the venipuncture sites).
• •6. Administration and use of the following drugs:
• •1. Past use of adalimumab or any other drugs that inhibit tumor necrosis factor alpha.
• •2. Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins, and dietary supplements, less than 14 days prior to the estimated date of randomization.
• •3. Taking medications, including over-the-counter drugs, which have a pronounced effect on hemodynamics and liver function (barbiturates, omeprazole, cimetidine, etc.), less than 30 days before the estimated date of randomization.
• •4. Using drugs that affect the immune status (cytokines and their inducers, glucocorticoids, etc.) less than 30 days before the estimated date of randomization.
• •5. Systemic use of antibacterial, antifungal, antiviral or antiprotozoal drugs less than 30 days before the estimated date of randomization.
• •6. Vaccination with live attenuated vaccines within 4 weeks before the estimated date of randomization.
• •7. Positive results of screening tests for HIV, hepatitis B and C viruses.
• •8. Results of conventional laboratory tests or investigations out of the reference ranges accepted at the study sites.
• •9. Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, kidneys, blood.
• •10. Acute infectious diseases less than 4 weeks before the estimated date of randomization, as well as chronic and other diseases that, in the Investigator's opinion, may affect the pharmacokinetics, safety, and immunogenicity of the IP.
• •11. Smoking more than 10 cigarettes a day.
• •12. Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 50 mL of spirits) or a history of alcoholism, drug addiction, or drug abuse.of blood or plasma within 60 calendar days prior to the expected date of randomization.
• •13. Donation of ≥450 mL of blood or plasma within 60 calendar days prior to the expected date of randomization.
• •14. Participation in any clinical studies in less than 90 calendar days before the date of randomization, if the subject received a medicinal product during the clinical study.
• •15. Previous participation in the same study if the subject was randomized and received the IP during the study.