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Completed

NCT Number: NCT03014947

MSB11022 in Healthy Subjects

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MSB11022

Drug

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

US-licensed Humira

Drug

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

Drug

Subject will receive single dose of 40 mg EU-approved Humira as a subcutaneous injection in the lower abdomen on Day 1.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fresenius Kabi SwissBioSim GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2017
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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