A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01418989
- Lead Sponsor
- Hoffmann-La Roche
- 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 volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tocilizumab [RoActemra/Actemra] auto-injector - 2 tocilizumab [RoActemra/Actemra] Syringe -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra 21 days Peak plasma concentration of RoActemra/Actemra 21 days
- Secondary Outcome Measures
Name Time Method Safety (Incidence of adverse events) 28 days