A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of Adalimumab (TUR01 and EU Sourced Humira®) in Healthy Subjects
Sponsor study identifier
interventional
168
1 country
1
Study Start
July 17, 2019
Actual (reported)Primary Completion
January 16, 2020
Actual (reported)Study Completion
January 16, 2020
Actual (reported)This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 16, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 17, 2019
Actual (reported)January 16, 2020
Actual (reported)January 16, 2020
Actual (reported)June 15, 2020
Actual (reported)June 19, 2020
Actual (reported)Area under the concentration-time curve from time 0 to infinity (AUCinf)
AUCinf = area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) + last observed concentration (Ct)/terminal rate constant (λz)
Day 1 - Day 71
Maximum serum concentration (Cmax)
Cmax
Day 1 - Day 71
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Day 1 - Day 71
Area under the concentration-time curve from time zero to 336 hours (AUC336)
Day 1 - Day 15
Area under the concentration-time curve from time zero to 672 hours (AUC672)
Day 1 - Day 29
Area under the concentration-time curve from time zero to 1008 hours (AUC1008)
Day 1 - Day 43
Area under the concentration-time curve from time zero to 1680 hours (AUC1680)
Day 1 - Day 71
Immunogenicity - Incidence of anti-drug antibodies to adalimumab
Day 1 - Day 71
Immunogenicity - Incidence of neutralizing antibodies
Day 1 - Day 71
Administered as a single 40 mg, subcutaneous dose
Administered as a single 40 mg, subcutaneous dose
PAREXEL International GmbH, Early Phase Clinical Unit Berlin
Berlin, 14050, Germany
Rainard Fuhr
Parexel
168 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2020
First Posted
June 19, 2020
Study Start
July 17, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 16, 2020
Actual (reported)Study Completion
January 16, 2020
Actual (reported)Last Updated
June 19, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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