NCT03014947

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

January 6, 2017

Last Update Submit

June 28, 2019

Conditions

Healthy Subjects

Keywords

MSB11022Humira®

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • Number of Subjects With Injection Site Reactions

    Baseline up to Day 71

  • +2 more secondary outcomes

Study Arms (3)

MSB11022

EXPERIMENTAL
Drug: MSB11022

US-licensed Humira

ACTIVE COMPARATOR
Drug: US-licensed Humira

EU-approved Humira

ACTIVE COMPARATOR
Drug: EU-approved Humira

Interventions

MSB11022DRUG

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

MSB11022
US-licensed HumiraDRUG

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

US-licensed Humira
EU-approved HumiraDRUG

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

EU-approved Humira

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects and healthy female subjects of non-childbearing potential aged 18 to 55 years, inclusive.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27285856RESULT

  • 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.

    PMID: 33263165DERIVED

Study Officials

  • Medical Responsible

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 9, 2017

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 1, 2019

Record last verified: 2019-06