First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects
Condition: Healthy
Intervention: BCD-089
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety,
      pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of
      the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will
      enroll 19 healthy male volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  singed informed consent

          -  male gender

          -  18-45 years of age inclusively

          -  BMI between18.5-30.0 kg/sq.m.

          -  absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine,
             respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at
             screening or/and in anamnesis

          -  parameters of complete blood count, blood biochemistry, and urinalysis do not exceed
             reference values, which are used at Study site laboratory

          -  normal hemodynamic parameters :

          -  absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and
             chronic inflammation

          -  absence of infections within 4 weeks before screening

          -  absence of mental disorders or other conditions, which may affect the ability of
             participant to follow Protocol

          -  absence of alcohol or drug addiction signs (incl. history of such addiction).

          -  volunteer's ability to follow Protocol procedures

          -  consent of volunteers and their sexual partners with childbearing potential to use
             adequate contraception during screening period and the main study part (14 days before
             randomization and 70 day after SC injection). This requirement is not applicable in
             surgically sterilized volunteers. Adequate contraception includes the use of one
             barrier method in combination with spermicides, intrauterine device / oral
             contraceptives in sexual partner

        Exclusion Criteria:

          -  history of use of monoclonal antibodies against IL-6 or IL-6R

          -  known severe allergy (anaphylaxis or multidrug intolerance)

          -  known intolerance to medicines containing monoclonal antibodies (murine, humanized,
             human) or to any excipients of BCD-089

          -  major surgery within 30 days prior screening

          -  severe infections (required hospitalization, parenteral use of antimicrobial agents)
             within 6 months prior the date of BCD-089 injection

          -  systemic use of antimicrobials within 2 months prior the date of BCD-089 injection

          -  more than 4 episodes of respiratory tract infections within 6 months prior the
             screening examination

          -  presence of any disorders which may affect pharmacokinetics of BCD-089

          -  history of fever which was equal or exceeded 40 degrees in Celsius

          -  - actual or prior depression, suicidal tendencies

          -  use of any medicines, vitamins, biologically active additives within 14 days prior the
             screening examination use of any medicines which affects hemodynamics or hepatic
             function within 30 days prior the screening examination simultaneous participation in
             any other clinical trial, as well as former participation in other clinical trials
             within 2 months before this study initiation.

        previous participation in this study