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A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects
Sponsor: LEO Pharma
Summary
The purpose of this trial is to compare the pharmacokinetics (PK), safety, tolerability and immunogenicity of a single dose of 300 mg tralokinumab administered as a 1 × X mL subcutaneous (SC) injection with Device A and 2 × Y mL consecutive SC injections with Device B.
Official title: A Randomized, Open-label, 2-period, 2-sequence Cross-over Trial to Compare the Pharmacokinetics of Tralokinumab of Two Presentations in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2021-02-08
Completion Date
2021-12-29
Last Updated
2026-04-24
Healthy Volunteers
Yes
Conditions
Interventions
Tralokinumab administered as 1 × X mL with Device A
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration
Tralokinumab administered as 2 × Y mL with Device B
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration
Locations (1)
LEO Pharma Investigational Site
Berlin, Germany