MSB11022 in Healthy Subjects

Healthy Subjects Clinical Trial

Official 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

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
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Subjects

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