A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers

Sponsor
Hoffmann-La Roche
Study ID
NCT01991990
Phase
PHASE4
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2014
Status verified
Oct 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL

Arms

  • Placebo Comparator: Placebo
  • Experimental: RoActemra/Actemra

Primary Outcome Measure

Neutrophil Redistribution Analysis on Day 4 (Neutrophil Nadir) [ Time Frame: Day 4 ]

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