A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects

Mental illness or other conditions that may affect the subject's ability to comply with the Study Protocol.

Any surgery performed less than 30 days before the screening.

Impossibility to insert a venous catheter for blood sampling (for example, due to skin disease at venipuncture sites).

History of severe hypersensitivity reactions (anaphylaxis or multiple drug allergy).

Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, and fully human) or any other components of the IP.

Administration and use of the following drugs:

• Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins, and dietary supplements, within less than 14 calendar days prior to estimated date of randomization;
• A history of receiving daratumumab and/or other anti-CD38 monoclonal antibodies.
• Taking medications, including over-the-counter drugs that have a pronounced effect on hemodynamics and liver function (barbiturates, omeprazole, cimetidine, etc.), within less than 30 days before the estimated date of randomization.
• Taking drugs that affect the immune status (cytokines and their inducers, glucocorticoids, etc.) within less than 60 days before the estimated date of randomization.
• Systemic use of antibacterial, antimycotic, antiviral or antiprotozoal drugs within less than 60 days before the estimated date of randomization.

Positive results of screening tests for HIV, hepatitis B and C viruses.

Positive result of indirect antiglobulin test (indirect Coombs test) at screening.

Conventional laboratory parameters or investigations out of the reference ranges accepted at the study sites.

Chronic diseases of the cardiovascular, bronchopulmonary, and neuroendocrine systems, as well as diseases of the gastrointestinal tract, kidneys, and blood.

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 PK parameters and safety of the IP.

Smoking over 10 cigarettes a day.

Consumption of more than 10 units of alcohol a 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.

Donation of ≥450 mL of blood or plasma within 60 calendar days prior to the expected date of randomization;

Participation in any clinical studies of medicinal products at the time of signing the informed consent or less than 30 calendar days before the expected date of randomization, if the subject received the medicinal product during the clinical study.

Previous participation in the same study if the subject was randomized and received the IP during the study.