NCT04674826

A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects

A Randomized, Open-label, 2-period, 2-sequence Cross-over Trial to Compare the Pharmacokinetics of Tralokinumab of Two Presentations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, randomized, open label, 2 period, 2 sequence cross over trial designed to compare the PK and to evaluate the safety, tolerability and immunogenicity of 300 mg tralokinumab administered as a 1 × X mL SC injection with Device A (test treatment \[T\]) and 2 × Y mL consecutive SC injections with Device B (reference treatment \[R\]) in healthy subjects. Additionally, the experience of tralokinumab being administered with Device A compared to Device B will be evaluated. After being informed about the study and the potential risks, all subjects giving written informed consent will be enrolled and randomized to 1 of 2 treatment sequences, Sequence TR or Sequence RT in a 1:1 ratio (i.e., subjects receive the 2 treatments in the specified order).

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-08
• Primary completion: 2021-12-29
• Completion: 2021-12-29
• First posted: 2020-12-19
• Last updated: 2025-02-24

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study
• FDA-regulated device study