MSB11022 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03014947
• Date of registration: 06/01/2017
• Prospective Registration: No
• Primary sponsor: Fresenius Kabi SwissBioSim GmbH
• Public title: MSB11022 in Healthy Subjects
• Scientific title: 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
• Date of first enrolment: May 2014
• Target sample size: 237
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03014947
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Medical Responsible

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: US-licensed Humira

Drug: EU-approved Humira

Drug: MSB11022

Primary Outcome(s)

Maximum Observed Serum Concentration (Cmax) [Time Frame: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours]

Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) [Time Frame: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours]

Primary: Area Under the Concentration-Time Curve From time Zero Extrapolated to Infinity (AUC [0-inf]) [Time Frame: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours]

Secondary Outcome(s)

Number of Subjects With Anti-drug Antibodies (ADA) for MSB11022 [Time Frame: Day 1 up to Day 71]

Apparent Total Clearance (CL/F) [Time Frame: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours]

Time to Reach Maximum Observed Serum Concentration (Tmax) [Time Frame: Pre-dose 0 hour, post-dose 4, 8 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours]

Number of Subjects With Injection Site Reactions [Time Frame: Baseline up to Day 71]

Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Death [Time Frame: Baseline up to Day 71]

Terminal Half-Life (t1/2) [Time Frame: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours]

Apparent Volume of Distribution During the Terminal Phase (Vz/F) [Time Frame: Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours]

Secondary ID(s)

2014-000662-21

EMR200588-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors