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Trial record 46 of 79996 for:    subjects

MSB11022 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03014947
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi SwissBioSim GmbH

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: MSB11022 Drug: US-licensed Humira Drug: EU-approved Humira Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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

Active Comparator: US-licensed Humira Drug: 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.

Active Comparator: EU-approved Humira Drug: 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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Number of Subjects With Injection Site Reactions [ Time Frame: Baseline up to Day 71 ]
  6. Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Death [ Time Frame: Baseline up to Day 71 ]
  7. Number of Subjects With Anti-drug Antibodies (ADA) for MSB11022 [ Time Frame: Day 1 up to Day 71 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014947


Locations
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Germany
Please contact the Merck KGaA Communication Center
Darmstadt, Germany
Sponsors and Collaborators
Fresenius Kabi SwissBioSim GmbH
Investigators
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Study Director: Medical Responsible

Publications of Results:
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Responsible Party: Fresenius Kabi SwissBioSim GmbH
ClinicalTrials.gov Identifier: NCT03014947     History of Changes
Other Study ID Numbers: EMR200588-001
2014-000662-21 ( EudraCT Number )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

Keywords provided by Fresenius Kabi SwissBioSim GmbH:
MSB11022
Humira®

Additional relevant MeSH terms:
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Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents