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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01418989

Enrollment

239

Registered

2011-08-17

Start date

2011-07-31

Completion date

2011-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGtocilizumab [RoActemra/Actemra] Syringe

Single dose administration with pre-filled syringe

DRUGtocilizumab [RoActemra/Actemra] auto-injector

Single dose administration with auto-injector

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra	21 days
Peak plasma concentration of RoActemra/Actemra	21 days

Secondary

Measure	Time frame
Safety (Incidence of adverse events)	28 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026