NCT02678988View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL

Enrollment

189

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions

Healthy Volunteer

Interventions

DEVICE

AI-1000 G2

The device will contain TCZ (180 milligrams per milliliter \[mg/mL\]) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS and assembled in the AI (AI-1000 G2).

DEVICE

PFS-NSD

The device will contain TCZ (180 mg/mL) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS-NSD.

DRUG

Tocilizumab

Participants will receive two single doses of 162 mg tocilizumab SC on Day 1 (Period 1) and Day 43 (Period 2), with a washout period of 6 weeks between the periods.

Trial Locations (3)

66219

Lenexa

84106

Salt Lake City

08053

Marlton

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY

NCT02678988 - 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 | Biotech Hunter | Biotech Hunter