Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers
Condition: Healthy
Intervention: Interferon beta-1a
Intervention description: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: interferon beta-1a; pharmacokinetics; pharmacodynamics; volunteers

Summary:

      This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and
      tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif®
      (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to
      demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability
      parameters after single subcutaneous injection. Each dtug will be administered to each
      volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least
      14 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent;

          -  Male gender;

          -  Age 18 - 45 years inclusive;

          -  Body mass index (BMI) (18,5 - 24,99 kg/m2);

          -  Healthy condition proven by the volunteer's history, global assessment and laboratory
             analysis results:

          -  Absence in past medical history and at screening of clinically significant
             dysfunctions of circulatory, respiratory, nervous, hematopoietic, endocrine and
             digestive systems, liver and kidneys;

          -  Haematology and biochemistry tests, urinalysis and thyroid hormone analysis results
             are within normal limits according to standards of the study site. Screening
             laboratory analyses should be performed not more than 14 days before volunteer's
             inclusion in the study;

          -  Hemodynamic parameters are within normal limits: systolic blood pressure - from 100 to
             139 mmHg, diastolic blood pressure - from 60 to 90 mmHg, heart rate - from 50 to 90
             bpm;

          -  Absence of history of chronic infection (tuberculosis) and chronic inflammation;

          -  Absence of HIV, hepatitis B and C virus, syphilis;

          -  Absence of acute infections within 4 weeks before inclusion in the study;

          -  Absence of psychiatric disorders and other conditions that can interfere with
             volunteer's ability to follow the study protocol, including depression;

          -  Well-being (in volunteer's opinion) within 30 days before participation in the study;

          -  Absence of history of systematic alcohol and drug abuse;

          -  Ability of the volunteer, in investigator's opinion, to follow the study protocol
             procedures and requirements;

          -  Willingness of volunteers and their sexual partners of childbearing potential to use
             reliable contraception methods starting from 2 weeks before inclusion into the study
             and until 4 weeks after receiving the last dose of the investigational products. This
             criterion is not applicable to patients who underwent surgical sterilization. Reliable
             contraceptive measures include one barrier method in combination with one of the
             following methods: spermicides, intrauterine device or oral contraceptives used by
             participant's partner;

          -  Consent to avoid alcohol intake within 24 hours before and 8 days after each
             administration of the test or reference drugs;

          -  Consent to avoid grapefruit juice (or other products containing grapefruit) intake
             within 72 hours before and 8 days after each administration of the study or reference
             drugs.

        Exclusion Criteria:

          -  Previous use of IFN-β1-containing medications at any time before inclusion;

          -  History of serious allergic reactions (anaphylaxis or multiple allergy);

          -  Known allergy or intolerance to interferons or any other components of study or
             reference drugs;

          -  Major surgery within 30 days before screening;

          -  Impossibility to install venous catheter for blood sampling (e.g. because of skin
             disorders at the sites of venipuncture);

          -  Diseases or other conditions that can interfere with the investigational drugs
             pharmacokinetics (e.g. chronic liver, kidney, blood, circulatory system, lung or
             neuroendocrine diseases, including diabetes mellitus and others);

          -  History of epileptic seizures;

          -  Regular oral or parenteral use of any medications including over-the-counter drugs,
             vitamins and nutritional additives within less than 2 weeks before inclusion in the
             study;

          -  Intake of medications, including over-the-counter drugs and biologically active
             additives that can influence hemodynamics, liver function etc. (barbiturates,
             omeprazole, cimetidine etc.) within less than 30 days before inclusion in the study;

          -  Intake of medications that influence immune status (cytokines and their inductors,
             glucocorticoids etc.) within less than 30 days before participation in the study;

          -  Smoking more than 10 cigarettes per day;

          -  Subjects who consume more than 10 units of alcohol per week or who have history of
             alcohol abuse or evidence of drug/chemical abuse (one unit of alcohol equals ½ l [500
             ml] of beer, one glass [200 ml] of wine or l shot glass [50 ml] of spirits);

          -  Donation of 450 ml and more of blood or plasma within 2 months before inclusion in the
             study;

          -  Participation in other clinical studies within less than 1 month before inclusion in
             the study or simultaneous participation in another clinical study;

          -  Previous participation in this study