Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
Condition: Healthy
Intervention: Adalimumab (BCD-057); Adalimumab (Humira)
Intervention description: Adalimumab is a monoclonal antibody against tumor necrosis factor alpha; Adalimumab is a monoclonal antibody against tumor necrosis factor alpha
Intervention MeSH terms: Adalimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 94.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical study is a phase 1 study which carried out to establish the pharmacokinetic
      equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar
      candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous
      injection in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subject has provided informed consent;

          -  male gender;

          -  18 - 45 years of age inclusively;

          -  a body mass index (BMI) between 18,5 and 30 kg/m2;

          -  absence of clinically significant 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. Evaluation of required
             laboratory parameters must be performed within 14 days before randomization;

          -  normal hemodynamic parameters: systolic BP 100 - 139 mm Hg, diastolic BP - 60 - 90 mm
             Hg, heart rate - 60 - 90 b/min;

          -  ECG results are normal for this age group;

          -  absence of chronic infections (HIV, syphilis, hepatitis В or С) and chronic
             inflammation;

          -  absence of active or latent tuberculosis;

          -  absence of infections within 4 weeks before randomization;

          -  absence of mental disorders or other conditions, which may affect the ability of
             participant to follow Protocol;

          -  health well-being (by volunteer's opinion) for at least 30 days before randomization;

          -  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;

          -  absence of alcohol or drug addiction signs (incl. history of such addiction);

          -  consent not to consume alcohol within 24 hours before SC injection of BCD-057/Humira
             and not to use more than 10 units of alcohol per week during the study (1 alcohol unit
             is equal ½ l of beer (1 pint), or 200 ml of wine, or 50 ml alcohol)

        Exclusion Criteria:

          -  history of adalimumab use or any other TNF inhibitors;

          -  known severe allergy (anaphylaxis or multidrug intolerance);

          -  known intolerance of monoclonal antibodies or any other excipients of BCD-057/Humira;

          -  major surgery within 30 days before ICF signing;

          -  presence of clinically significant hepatic, renal, gastrointestinal, cardiovascular,
             endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic
             abnormality at screening or/and in anamnesis.

          -  infections which required hospitalization, parenteral anti-infectives within 6 months
             before randomization;

          -  positive results of tests for HIV-1 and HIV-2 antibodies, positive Hbs-Ag, HBc IgM,
             total antibodies against HCV, positive results of RPR-test;

          -  more than 4 episodes of acute respiratory infection within 6 months before
             randomization;

          -  any malignancy (present or history);

          -  tuberculosis, including latent forms;

          -  shingles (present or history).

          -  history of seizures;

          -  any disorders or other conditions, which may affect pharmacokinetics of BCD-057/Humira
             (e.g. chronic liver diseases, chronic kidney diseases, cardiovascular disorders, lung
             disorders, endocrine diseases, etc.).

          -  use of systemic antimicrobial or antifungal medicines within 2 months before
             randomization;

          -  regular oral or parenteral use of any medicines, vitamins, biologically active
             additives within two weeks before signing of ICF;

          -  any use of medicines, vitamins, biologically active additives within 30 days before
             signing of ICF;

          -  use of medicines, which may influence on immunity within 30 days before signing of
             ICF;

          -  vaccination within 4 weeks prior randomization;

          -  smoking of more than 10 cigarettes per day;

          -  use of alcohol, which exceeds 10 units per week (1 alcohol unit is equal ½ l of beer
             (1 pint), or 200 ml of vine, or 50 ml alcohol). History of alcohol or drug addiction;

          -  donation of more than 450 ml of blood or plasma within 2 months prior randomization;

          -  simultaneous participation in any other clinical trial, as well as former
             participation in other clinical trials within 3 months before this study initiation;

          -  previous participation in this study.