A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers

Status:	Completed
Conditions:	Healthy Studies
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 65
Updated:	8/3/2016
Start Date:	February 2016
End Date:	June 2016

The study consists of an eligibility screening period, two study periods involving single
doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover
design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy
participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled
syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The
total duration of the study is up to 16 weeks from screening to follow-up. After screening,
eligible participants will be randomly assigned to one of the two possible treatment
sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by
AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper
arm). All participant groups will receive a total of two TCZ administrations each.

Inclusion Criteria:

- Male participants and their partners of child-bearing potential must be willing to
use two effective contraceptive methods

- Female participants must be either postmenopausal or surgically sterile

- Intact normal skin in the area for intended injection

- Body weight less than (<) 150 kilograms (kg)

- Have no contraindications from the following: a detailed medical and surgical
history, a complete physical examination, including vital signs, 12-lead electro
cardio gram (ECG), hematology, blood chemistry, serology, and urinalysis

Exclusion Criteria:

- Participants with any known active current or history of recurrent Infectious disease

- Positive result on hepatitis B surface antigen, hepatitis C antibody, or human
immunodeficiency virus-1 (HIV-1) and HIV-2 at screening

- A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular,
or allergic disease

- Evidence of malignant disease, or malignancies diagnosed within the previous 5 years

- Use of or being dependent within the last 12 months on any substances of abuse,
including a relevant past history of alcohol abuse

- Participants with a history of, or currently active primary or secondary
immunodeficiency

- Participants who smoke more than 10 cigarettes per day or equivalent in tobacco

- Clinically relevant deviation from normal in the physical examination, including
vital signs

- Clinically relevant ECG abnormalities on screening

- Evidence of atrial fibrillation, atrial flutter, right or left bundle branch block,
Wolf-Parkinson-White syndrome, or cardiac pacemaker or any other significant cardiac
abnormalities

- Known allergy to TCZ or any other ingredient in the subcutaneous (SC) formulation

- History of severe allergic or anaphylactic reactions to human, humanized, or murine
monoclonal antibodies

- Known coagulopathy

- Clinically significant abnormalities in laboratory test results

- Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to
study drug administration

We found this trial at

sites

Clinical Trial Facility in Marlton New Jersey

Marlton, New Jersey 08053

from

Marlton, NJ