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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03014947
Other study ID # EMR200588-001
Secondary ID 2014-000662-21
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2014
Est. completion date December 2014

Study information

Verified date June 2019
Source Fresenius Kabi SwissBioSim GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 237
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MSB11022
Subjects will receive single dose of 40 milligram (mg) MSB11022 as a subcutaneous injection in the lower abdomen on Day 1.
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fresenius Kabi SwissBioSim GmbH

References & Publications (1)

Hyland E, Mant T, Vlachos P, Attkins N, Ullmann M, Roy S, Wagner V. Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira(®) in healthy subjects. Br J Clin Pharmacol. 2016 Oct;82(4):983-93. doi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Number of Subjects With Injection Site Reactions Baseline up to Day 71
Secondary Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Death Baseline up to Day 71
Secondary Number of Subjects With Anti-drug Antibodies (ADA) for MSB11022 Day 1 up to Day 71
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