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COMPLETED
NCT04674826
PHASE1

A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects

Sponsor: LEO Pharma

View on ClinicalTrials.gov

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

DRUG

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

DEVICE

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