A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
Condition: Pharmacokinetics; Safety Issues
Intervention: Bevacizumab
Intervention description: Single-dose infusion
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: Male
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bevacizumab; Biosimilar; Antineoplastic Agents; Bioequivalence; Immunogenicity; safety; healthy male volunteers

Summary:

      The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new
      formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already
      marketed formulations of Bevacizumab Avastin® (reference product) and Cizumab® (Indian
      origin), to establish similarity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study subjects must be willing and able to provide written informed consent

          -  Subjects of study, volunteers, adults, healthy.

          -  Study subjects whose safety and complementary laboratory tests are within normal
             values or which, in the Investigator's opinion, do not have clinical relevance: blood
             count, erythrosedimentation, hepatogram, urea, creatinine, glucose, coagulogram,
             serology for HIV, hepatitis B , hepatitis C, complete urinalysis, detection of drugs
             of abuse in urine and electrocardiogram.

          -  Sample taken for immunogenicity

          -  Body mass index between 19 and 27 kg / m2 at the screening visit.

          -  Subjects of study preferably non-smokers.

          -  Men with a partner of childbearing age must agree that their partner uses an adequate
             contraceptive method before entering the study and for at least 3 months after the end
             of the study. It is understood as a contraceptive method suitable to any hormonal
             contraceptive method or intrauterine device (which should be established before the
             start of the study) and the use of a spermicide as a barrier method. The use of a
             barrier method alone or sexual abstinence is not considered adequate.

          -  Subjects must agree not to donate sperm during the study and for 4 months after
             treatment.

        Exclusion Criteria:

          -  History of pulmonary, gastrointestinal, hepatic, renal, hematological,
             endocrine-metabolic, neurological or psychiatric illnesses (depressive disorders, in
             particular) at the time of taking the anamnesis and the physical examination during
             the first visit of the Protocol of Clinical research.

          -  History of gastrointestinal surgeries (except uncomplicated appendectomy, at least 3
             months old).

          -  History of major surgery, surgical biopsy and / or history of significant trauma
             within 1 month of the screening visit.

          -  Specifically, pre-existing gastrointestinal conditions such as abdominal fistulas,
             gastrointestinal perforation within 6 months of the screening visit.

          -  Specifically, preexisting gastrointestinal conditions such as acute or subacute
             intestinal occlusion.

          -  Specifically, history of inflammatory bowel disease.

          -  History of hemorrhagic diseases and / or coagulopathies and / or thromboembolic
             events.

          -  History of heart and vascular diseases: specifically myocardial infarction, unstable
             angina, cerebrovascular accident, uncontrolled arterial hypertension and cardiac
             arrhythmias.

          -  Background or current history of alcohol or drug abuse.

          -  Blood donation within 3 months prior to selection.

          -  Administration of any other drug under investigation or participation in a clinical
             research trial within 3 months prior to the planned participation in this Clinical
             Research Protocol.

          -  History of clinically significant diseases or disorders that, in the opinion of the
             Investigator, may impede the participation of the study subject for safety reasons or
             that may influence the results of the same as well as the ability of the study subject
             to participate in the Clinical Research Protocol.

          -  History of hypersensitivity to bevacizumab and / or any of the excipients.

          -  Study subjects who present contraindications to therapy

          -  Study subjects who have received (2 weeks before) or are receiving aspirin or
             clopidogrel

          -  The study subjects must have suspended any pharmacological treatments at least 2 weeks
             before the initiation of this Clinical Research Protocol.

          -  Non-cooperative study subjects

          -  Study subjects employed by the Researcher or the Clinical-Pharmacokinetic Research
             Unit, with direct participation in the Clinical Research Protocol or other clinical
             protocols under the Direction of the Researcher or the Clinical-Pharmacokinetic
             Research Unit

          -  Physical findings and laboratory analyses:

          -  Cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological,
             endocrine-metabolic, neurological disease or psychiatric disorder (depressive
             disorders, in particular)

          -  Evidence of ulcers, unhealed wounds or bone fractures.

          -  Clinically significant abnormalities in any laboratory analysis, and electrocardiogram

          -  Positive serology for HIV, hepatitis B, hepatitis C