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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: tocilizumab [RoActemra/Actemra] auto-injector; Drug: tocilizumab [RoActemra/Actemra] Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01418989

NP25539

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

239 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra] auto-injector

2

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra] Syringe