Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man

Exclusion Criteria

• •1. Aggravated allergic anamnesis.
• •2. Hypersensitivity to pertuzumab and / or other substances that are part of the study drug.
• •3. Any vaccination up to 30 days before the expected date of administration of the drug according to medical history.
• •4. Drug intolerance.
• •5. Known intolerance to monoclonal antibody drugs (mouse, chimeric, humanized, human) according to medical history.
• •6. The results of laboratory analyzes provided for by the protocol are outside the established normative indicators of the investigator site.
• •7. Oncological diseases according to medical history.
• •8. Acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, mental illness.
• •9. More than 4 episodes of respiratory infections in the last 6 months prior to screening.
• •10. Surgical interventions on the gastrointestinal tract (with the exception of appendectomy).
• •11. Acute infectious diseases less than 4 weeks prior to study entry.
• •12. Taking drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before the start of this study.
• •13. Regular drug intake less than 2 weeks before the start of the study.
• •14. Systolic blood pressure less than 100 mm Hg. Art. or above 130 mm Hg. Art.; diastolic blood pressure less than 60 mm Hg. Art. or above 90 mm Hg. Art.; Heart rate less than 60 bpm or more than 90 bpm; respiratory rate less than 12 and more than 20 per minute
• •15. Donation of blood (450 ml of blood or more) less than 3 months before the start of the study.
• •16. Participation in clinical drug trials less than 3 months before the start of this study.
• •17. Taking more than 10 units of alcohol per week (where each unit is equal to 50 ml of strong alcoholic beverages or 500 ml of beer) or anamnestic information about alcoholism, drug addiction, drug abuse.
• •18. Smoking more than 10 cigarettes a day.
• •19. Any reason that, in the opinion of the investigator, would prevent a volunteer from participating in the study.
• •20. Mental, physical and other reasons that do not allow the subject adequately assess his behavior and correctly fulfill the conditions of the research protocol.
• •21. Special diet (eg vegetarian, vegan) or lifestyle (including night work and extreme physical activity such as heavy lifting) that may interfere with the study.
• •22. Volunteers who are expected to have problems with placing venous catheters or performing veinpuncture.
• •23. Depression according to medical history.
• •24. Insomnia according to medical history.
• •25. Inability to follow the schedule of study visits by a volunteer.