MSB11022 in Healthy Subjects

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH
• Treatments: Adalimumab

Criteria

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.