MSB11022 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: MSB11022; Drug: US-licensed Humira; Drug: EU-approved Humira

• Registration Number: NCT03014947
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSB11022	MSB11022	-
US-licensed Humira	US-licensed Humira	-
EU-approved Humira	EU-approved Humira	-

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Death	Baseline up to Day 71
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
Number of Subjects With Injection Site Reactions	Baseline up to Day 71
Number of Subjects With Anti-drug Antibodies (ADA) for MSB11022	Day 1 up to Day 71
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