A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers

Inclusion Criteria:

• Written informed consent to participate in the study;

• Men and women aged 18 to 45 years, inclusive, at the time of signing the informedconsent form;

• Verified diagnosis "healthy" (based on a detailed medical history, in the absence ofdeviations from normal values during a physical examination, assessment of vitalsigns, as well as according to laboratory tests, electrocardiography and digitalfluorography/digital pulmonary radiography);

• Body weight from 50.0 to 90.0 kg, inclusive; body mass index from 18.5 to 29.9kg/m2, inclusive;

• Volunteer's agreement to adhere to adequate methods of contraception for 3 monthsafter administration of the study or reference drug;

• The volunteer's consent not to become a donor of blood and/or its components duringthe entire study and for 30 days after its completion.

Exclusion Criteria:

• Hypersensitivity to any of the components of the study or reference drug; a historyof allergic reactions requiring drug treatment;

• Any history of tocilizumab use; use of tumor necrosis factor-alfa (TNF-alpha)inhibitors less than 3 months before randomization;

• The presence of acute and chronic diseases of the cardiovascular system, respiratorysystem, nervous, immune and endocrine systems, gastrointestinal tract, liver andbiliary tract, kidneys and urinary tract, blood and lymphatic system, mentalillness, tuberculosis;

• History of an autoimmune disease;

• History of cancer;

• Acute infectious diseases that resolved less than 28 days before randomization;

• Use of prescription medications less than 28 days or 5 half-lives of the drug (whichever is longer) or systematic use of over-the-counter medications/dietarysupplements less than 14 days before randomization;

• Blood donation or blood loss (450 ml of blood or more) less than 3 months beforerandomization and/or planned blood donation in any quantity during participation inthe study;

• Participation in clinical trials of medicinal products less than 3 months or 5half-lives of the study drug (whichever is longer) before randomization in thisstudy;

• Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit isequal to 30 ml of ethyl alcohol) or information about a history of alcoholism, drugaddiction, or drug abuse;

• Positive test for the presence of alcohol in exhaled air;

• Positive urine test for the content of narcotic and potent drugs;

• Positive test for hepatitis B or C, HIV or syphilis;

• Any surgical interventions planned during the period of participation in the study;

• Depot injections or use of implants of any other drugs less than 3 months beforerandomization;

• Immunization with any vaccine less than 3 months before randomization;

• Special lifestyle (work at night);

• Pregnancy or breastfeeding period;

• Unwillingness or inability to comply with the recommendations prescribed by thisprotocol;

• Other reasons that, in the opinion of the investigator and/or Sponsor, prevent thevolunteer from participating in the study or create an unreasonable risk.