Healthy Subjects
Conditions
Keywords
MSB11022, Humira®
Brief 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.
Interventions
DRUGMSB11022
Subjects will receive single dose of 40 milligram (mg) MSB11022 as a subcutaneous injection in the lower abdomen on Day 1.
Subject will receive single dose of 40 mg US-licensed Humira as a subcutaneous injection in the lower abdomen on Day 1.
Subject will receive single dose of 40 mg EU-approved Humira as a subcutaneous injection in the lower abdomen on Day 1.
Sponsors
Fresenius Kabi SwissBioSim GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Area Under the Concentration-Time Curve From time Zero Extrapolated to Infinity (AUC [0-inf]) | 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 |
| Maximum Observed Serum Concentration (Cmax) | 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]) | 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
| Measure | Time frame |
|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) | 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) | 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 Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Death | Baseline up to Day 71 |
| Apparent Total Clearance (CL/F) | 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 |
| Terminal Half-Life (t1/2) | 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 Anti-drug Antibodies (ADA) for MSB11022 | Day 1 up to Day 71 |
| Number of Subjects With Injection Site Reactions | Baseline up to Day 71 |
Outcome results
None listed