Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers
Condition: Healthy
Intervention: Darbepoetin alfa
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: darbepoetin alfa; pharmacokinetics; pharmacodynamics; healthy volunteers

Summary:

      This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and
      safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen
      Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate
      the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single
      subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a
      dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval
      of at least 25 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent

          -  Male gender

          -  Age 18 - 45 years inclusively

          -  Body mass index (BMI) 19 - 29 kg/m2 inclusively

          -  Hemoglobin level 120-160 g/l (12 - 16 g/dL) inclusively during 14 days prior to first
             study drugs administration

          -  White blood cells count ≥3,0×109/L, Platelet count ≥140×109/L during 14 days prior to
             first study drugs administration

          -  Subjects must be in good health as determined by a medical history, medical
             examination, electrocardiogram, serum biochemistry, haematology, serology and
             urinalysis

          -  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 48 hours after each
             administration of the test or reference drugs

        Exclusion Criteria:

          -  Clinically significant abnormalities on ECG or in laboratory tests, which could
             interfere with the objective of the study or the safety of the volunteer.

          -  Clinically significant illness within 4 weeks prior to the screening visit

          -  Subjects with past or present history of liver disease, angina, renal disease,
             hypertension, epilepsy, cardiovascular, cerebrovascular, peripheral vascular disease
             or thrombocytosis

          -  History of any oncological disease

          -  Prior exposure to any erythropoietins, darbepoetin

          -  Prior exposure to IV iron supplementation (within 2 years before randomisation)

          -  Subjects who have used any medication, including over-the-counter drugs, herbal
             medications, and nutritional supplements within 14 days prior to IDs administration
             with the exception of paracetamol (acetaminophen) up to 3g per day or ibuprofen up to
             1g per day

          -  Subjects who smoke more than 10 cigarettes per day

          -  Subjects who have donated more than 450 ml of blood within the 1 month prior to ID
             injection

          -  Epileptic seizures within the 6 months prior to ID injection

          -  Major surgery within 1 month prior to the enrollment into the study

          -  Inability to install intravenous catheter (e.g., due to skin disease)

          -  Subjects who have received any experimental drug within 3 months preceding the 1st ID
             administration

          -  Subjects who have a clinically significant history of drug hypersensitivity or
             allergic disease

          -  Possibility that the subject will not cooperate with the requirements of the protocol
             as set out in the volunteer information

          -  Subjects who consume excessive amounts of caffeine (more than 5 cups of coffee per
             day)

          -  Participation in any other clinical study or any preceding participation in other
             studies within 3 months prior to the 1st ID administration