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OpenTrials
Completed

NCT Number: NCT01418989

A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers

This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montpellier, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers, age 18 to 65 years inclusive
  • Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection
  • A body mass index (BMI) between 18 to 32 kg/m2 inclusive

Exclusion criteria

  • Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease

Treatment and study plan

tocilizumab [RoActemra/Actemra] Syringe

Drug

Single dose administration with pre-filled syringe

tocilizumab [RoActemra/Actemra] auto-injector

Drug

Single dose administration with auto-injector

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra

    Time frame: 21 days

  2. Peak plasma concentration of RoActemra/Actemra

    Time frame: 21 days

Secondary outcomes

  1. Safety (Incidence of adverse events)

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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