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NCT01418989 Clinical Trial

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

Healthy Volunteer Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01418989
Other study ID # NP25539
Secondary ID
Status Completed
Phase Phase 1
First received August 16, 2011
Last updated November 1, 2016
Start date July 2011
Est. completion date November 2011

Study information
Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 239
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tocilizumab [RoActemra/Actemra] Syringe
Single dose administration with pre-filled syringe
• tocilizumab [RoActemra/Actemra] auto-injector
Single dose administration with auto-injector

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra 21 days No
Primary Peak plasma concentration of RoActemra/Actemra 21 days No
Secondary Safety (Incidence of adverse events) 28 days No
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