The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
Condition: Healthy
Intervention: BCD-066; Aranesp
Intervention description: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg; Aranesp will be administered once a week intravenously in a dose 1 µg/kg
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 57.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled,
      randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and
      safety of multiple intravenous injections of BCD-066 and Aranesp®.

      The purpose of the study is to confirm the equivalent pharmacokinetics, pharmacodynamics,
      safety, and tolerability of multiple IV injections of BCD-066 and Aranesp® in healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent form

          2. Men from 18 to 45 years old (inclusive)

          3. BMI within the normal limits (18.5 to 30 kg/m2)

          4. Hemoglobin from 120 g/L to 150 g/L and hematocrit 41% to 49% at screening (before the
             first injection)

          5. Serum transferring 2.15 g/L to 3.6 g/L; serum ferritin from 20 μg/L to 250 μg/L

          6. Vitamin B12 from 187 pcg/mL to 883 pcg/mL; folic acid from 3.1 ng/mL to 20.5 ng/mL

          7. Endogenous serum erythropoietin < 30 mIU/mL at screening

          8. The subject is verified as "Healthy" according to results of standard clinical,
             laboratory and instrumental tests

          9. Subject's ability (in the investigator's opinion) to follow the protocol procedures

         10. The subject and his sexual partner with retained childbearing potential consent to
             implement reliable contraceptive methods starting 2 weeks before inclusion in the
             study and up to 2 weeks after the last dose of the test/reference drug. This
             requirement does not apply to surgically sterile subjects. Reliable contraception
             methods mean one barrier method in combination with one of the following: spermicides,
             intrauterine device and/or oral contraceptives used by the subject's partner.

         11. The subject agrees not to drink alcohol for 24 h prior to each injection of the
             test/reference drug and for 72 h after the injection.

        Exclusion Criteria:

        1. Psychiatric disorders or other conditions that can affect the ability of the subject to
        follow the study protocol 2. Acute infections within 4 weeks before the study start 3.
        Results of laboratory and/or instrumental tests are outside the normal range 4. Chronic
        cardiovascular, bronchial and/or pulmonary, neuroendocrine GI, liver, kidney, and blood
        diseases, including ischemic heart disease, arterial hypertension, peripheral vascular
        and/or cerebral vascular disorders, and thrombocytosis 5. A history of chronic hemorrhages

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