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

Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: tocilizumab [RoActemra/Actemra] auto-injector (Drug); tocilizumab [RoActemra/Actemra] Syringe (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Please reference Study ID Number: NP25539, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

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.

Clinical Details

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)

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

Primary outcome:

Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra

Peak plasma concentration of RoActemra/Actemra

Secondary outcome: Safety (Incidence of adverse events)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Please reference Study ID Number: NP25539, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

Montpellier 34094, France; Recruiting

Rennes 35000, France; Recruiting

Additional Information

Starting date: July 2011
Last updated: December 5, 2011

Page last updated: December 08, 2011

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