A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers
Condition: Healthy Volunteer
Intervention: placebo; tocilizumab [RoActemra/Actemra]
Intervention description: Single i.v. infusion; Single 8 mg/kg i.v. infusion
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics
      effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and
      survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV)
      RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil
      kinetics data will be collected for all subjects up to Day 10 of the study. Following the
      last study visit on Day 10, all subjects will attend two further safety follow-up visits on
      Day 28 and Day 56.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male aged between 18 and 65 years inclusive

          -  Healthy as determined by screening assessments

          -  Body mass index (BMI) 18 to 30 kg/m2 inclusive

          -  Non-smoker

          -  Must agree to use a barrier method of contraception supplemented with spermicide
             during the treatment period and for at least 150 days after the last dose of study
             drug

        Exclusion Criteria:

          -  Participation in a clinical study with an investigational drug within 3 months or at
             least 5 half-lives (whichever is longer) prior to dosing

          -  Current or past history of smoking within 6 months

          -  Previous exposure to therapeutic monoclonal antibodies in the past 6 months prior to
             screening

          -  Current or clinically significant history of any condition that, in the opinion of the
             investigator, would: place the subject at undue risk; invalidate the giving of
             informed consent; interfere with PK or PD data; or interfere with the ability of the
             subject to complete the study

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies

          -  Any recurrent infections; infection requiring antibiotic treatment in the 6 weeks
             prior to dosing; mononucleosis in the 6 months prior to dosing; known HIV, Hepatitis
             B, or Hepatitis C; or active infection at the time of screening

          -  Active tuberculosis (TB) requiring treatment within the previous 3 years.

          -  Evidence of active malignant disease, malignancies diagnosed within the previous 10
             years (except basal cell carcinoma of the skin that has been excised and cured), or
             breast cancer diagnosed within the previous 20 years

          -  Primary or secondary immunodeficiency

          -  Autoimmune disease

          -  Use or dependence on substance of abuse

          -  Alcohol abuse or average weekly intake greater than 2 units per day

          -  Screening or baseline resting heart rate < 45 or >90 beats per minute

          -  Major surgery within 8 weeks prior to screening

          -  Major illness in the 3 months prior to dosing

          -  Biliary obstruction

          -  Current or past history of diverticulitis