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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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