MedTrace Logo

Adalimumab PK Bioequivalence Study to EU and US Sourced Humira

NCT02472912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2022-03-11

No results posted yet for this study

Summary

Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults.

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).

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Magdalena Petkova, MD · SGS Belgium NV

  • Fausto Berti · Mylan GmbH

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472912 on ClinicalTrials.gov