Adalimumab PK Bioequivalence Study to EU and US Sourced Humira

PHASE1CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

May 31, 2015

Study Completion Date

June 30, 2015

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

BMO-2

Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).

BIOLOGICAL

EU-Humira

Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)

BIOLOGICAL

US-Humira

Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).

Trial Locations (1)

Unknown

SGS Belgium NV, Antwerp

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mylan GmbH

INDUSTRY

lead

Mylan Inc.

INDUSTRY