Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
Condition: Healthy Subjects
Intervention: BCD-148; Soliris
Intervention description: single intravenous infusion of BCD-148 (900 mg); single intravenous infusion of Soliris (900 mg)
Intervention MeSH terms: Eculizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics,
      Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and
      Soliris® in Healthy Volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed ICF for participation in the study

          2. Men from 18 to 45 years old (inclusive) at the time of signing the ICF

          3. BMI within the normal limits (18.0 to 30 kg/m2)

          4. The subject is able to follow the Protocol procedures (in the investigator's opinion)

          5. The subject is verified as "Healthy" according to results of standard clinical,
             laboratory and instrumental tests

          6. Normal hemodynamic parameters: systolic BP from 90 mmHg to 130 mmHg; diastolic BP from
             60 mmHg to 90 mmHg; HR from 60 bpm to 90 bpm

          7. The subject and his sex partner of childbearing potential consent to implement
             reliable contraceptive methods from the moment the subject signs the ICF and until the
             subject completes the study. This requirement does not apply to those subjects who had
             undergone surgical sterilization. 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.

          8. The subject agrees not to drink alcohol for 24 h prior to the infusion of the
             test/reference drug and for the entire period while the subject is in the study.

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        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 signing the ICF

          3. Results of laboratory and/or instrumental tests are outside the site's normal range

          4. Any surgery done within 30 days before the screening or planned within 30 days after
             the subject completes the study

          5. Impossibility to insert an intravenous catheter for blood collection (e.g., because of
             a skin condition at the venipuncture site)

          6. A history of allergies

          7. Known hypersensitivity to any component of BCD-148 or Soliris®, murine proteins or
             other drug components; hypersensitivity to any component of the meningococcal vaccine

          8. The subject had used any medications that significantly affect hemodynamics, liver
             function, etc. (barbiturates, omeprazole, cimetidine, etc.) within 30 days before
             signing the ICF and/or the subject needs any medications (other than the study drugs)
             to be taken during the entire study period

          9. The subject had previously used eculizumab and/or other therapeutic monoclonal
             antibodies against complement C5

         10. Regular use (oral or parenteral) of any drugs, including OTC products, vitamins or
             biologically active supplements within 14 calendar days before signing the ICF

         11. A history of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to
             signing the ICF

         12. Acute or chronic infections or other diseases that, in the investigator's opinion, may
             affect the PK, PD or safety of the study products

         13. HIV, HCV, HBV infection, syphilis.

         14. Meningococcal infection in the past (documented or mentioned verbally by the subject)

         15. Vaccination within 4 weeks before the planned infusion date, except for vaccination
             against Neisseria meningitidis given to all subjects in the screening period

         16. The subject refuses to get a vaccination against Neisseria meningitidis during the
             screening period .

         17. The subject smokes more than 10 cigarettes per day

         18. The subject consumes more than 10 units of alcohol per week (1 unit equals to 0.5 L of
             beer, 200 mL of wine or 50 mL of a strong alcohol beverage) or has a history of
             alcohol, recreational drug or medication abuse, or tests positive for alcohol and/or
             psychoactive substances during the screening examination

         19. Donation of ≥ 450 mL of blood or plasma within 60 calendar days before signing the
             ICF.

         20. Participation in any drug clinical studies within 30 calendar days prior to signing
             the informed consent form and through the entire period of study participation.

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