Status:
COMPLETED
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 volunte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01418989
Start Date
July 1 2011
End Date
November 1 2011
Last Update
November 2 2016
Active Locations (2)
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1
Montpellier, France, 34094
2
Rennes, France, 35042