NCT03014947

MSB11022 in Healthy Subjects

A Phase I, Randomized, Double-Blind, Parallel-Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of MSB11022, US-Reference Product, and EU-Reference Medicinal Product (Humira®) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Fresenius Kabi SwissBioSim GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal Product (RMP) (Humira®) in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	MSB11022	Subjects will receive single dose of 40 milligram (mg) MSB11022 as a subcutaneous injection in the lower abdomen on Day 1.
DRUG	US-licensed Humira	Subject will receive single dose of 40 mg US-licensed Humira as a subcutaneous injection in the lower abdomen on Day 1.
DRUG	EU-approved Humira	Subject will receive single dose of 40 mg EU-approved Humira as a subcutaneous injection in the lower abdomen on Day 1.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2017-01-09
• Last updated: 2019-07-01