MSB11022 in Healthy Subjects

Fresenius Kabi

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: MSB11022

Drug: US-licensed Humira

Drug: EU-approved Humira

Study type

Interventional

Funder types

Industry

Identifiers

NCT03014947

EMR200588-001

2014-000662-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

237 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects and healthy female subjects of non-childbearing potential aged 18 to 55 years, inclusive.
Other protocol defined inclusion criteria could apply.

Exclusion criteria

Concurrent or history infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection.
Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay.
Concurrent or history of demyelinating disease (multiple sclerosis, etc.).
Concurrent or history of congestive cardiac failure.
Concurrent or history of allergic symptoms such as asthma bronchial, drug-induced rash, and urticaria, which, in the judgment of the investigator, may affect participation in this clinical study.
Concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, and/or hematological function disorders, which, in the judgment of the investigator or any of the sub investigators, may affect participation in this clinical study.
Other protocol defined exclusion criteria could apply.