| Eligibility |
Inclusion Criteria:
- Healthy Volunteers, Men, 18 to 45 years old.
- Body mass index 18,5 - 30,0 kg/m2.
- Availability of written informed consent of the volunteer to participate in the study
in accordance with applicable law.
- Volunteers should behave adequately, coherent speech should be observed.
- Volunteer consent to use an adequate method of contraception (barrier methods of
contraception in combination with one of the following: non-hormonal intrauterine
device; condom with intravaginal spermicide; cervical caps with spermicide; diaphragm
with spermicide in the sexual partner) during the entire period of participation in
the study and at least 6 months after the use of the study drug/comparator drug.
- The verified diagnosis is "healthy": the absence of pathology from the
gastrointestinal tract, liver, kidneys, cardiovascular and bronchopulmonary systems,
central nervous system (preliminary standard clinical, laboratory and instrumental
studies did not reveal the presence of any diseases).
- Negative blood tests for HIV, syphilis and hepatitis (HBsAg and anti-HCV).
- LVEF = 60% according to ECHO-CG.
- Negative urine test for drug and drug abuse.
- Negative breath alcohol test.
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.
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