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CompletedNCT03014947Updated Jul 1, 2019

MSB11022 in Healthy Subjects

A Phase 1 interventional study of MSB11022 and US-licensed Humira in Healthy Subjects, sponsored by Fresenius Kabi SwissBioSim GmbH. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-01.

Sponsored by Fresenius Kabi SwissBioSim GmbH (part of Fresenius Kabi) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
237
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • MSB11022
  • Humira®
03

In context

Lead sponsor

Fresenius Kabi SwissBioSim GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Unclear whether first submitted before or after Fresenius Kabi SwissBioSim GmbH became part of Fresenius Kabi.

Browse Fresenius Kabi SwissBioSim GmbH studies →All Fresenius Kabi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
237 participants (actual)

Study arms

  • Experimental
    MSB11022

    Drug: MSB11022

  • Active comparator
    US-licensed Humira

    Drug: US-licensed Humira

  • Active comparator
    EU-approved Humira

    Drug: EU-approved Humira

Interventions

  • DrugMSB11022

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

  • DrugUS-licensed Humira

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

  • DrugEU-approved Humira

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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((R)) in healthy subjects. Br J Clin Pharmacol. 2016 Oct;82(4):983-93. doi: 10.1111/bcp.13039. Epub 2016 Jul 28. PubMed 27285856 ↗
  • Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1. PubMed 33263165 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2017
First posted
Jan 9, 2017
Start
May 2014
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
Jul 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03014947
Lead sponsor
Fresenius Kabi SwissBioSim GmbH
Responsible party
Sponsor
First posted
Jan 9, 2017
Start date
May 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jul 1, 2019

Study contacts

Medical Responsible
study director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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