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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tralokinumab administered as 1 × X mL with Device A; Device: Tralokinumab administered as 2 × Y mL 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).

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • LEO Pharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female aged 18 to 55 years (both included) at the time of Screening.
• Female subjects of childbearing potential must use a highly effective form of birth control throughout the trial and at least for 16 weeks after last administration of the investigational medicinal product (IMP) and must have a negative serum pregnancy test at Screening.

Exclusion Criteria:

• Systemic (non biologic) or topical treatment within 21 days prior to first dose administration unless in the opinion of the Investigator the medication will not interfere with the trial procedures or compromise safety.
• Active tuberculosis or history of incompletely treated tuberculosis based on medical history or medical report.
• History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at Screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
• History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization.
• History of a helminth parasitic infection within 6 months prior to the date of informed consent that has not been treated with or has failed to respond to standard of care therapy.
• History of anaphylaxis or severe allergic reaction following any biologic therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TR (Test-Reference); Treatment period 1: 300 mg tralokinumab, single subcutaneous dose, 1 × X mL Device A (Test treatment, T) Treatment period 2: 300 mg tralokinumab, subcutaneous dose, 2 × Y mL Device B (Reference treatment, R)	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
Experimental: RT (Reference-Test); Treatment period 1: 300 mg tralokinumab, subcutaneous dose, 2 × Y mL Device B (Reference treatment, R) Treatment period 2: 300 mg tralokinumab, single subcutaneous dose, 1 × X mL Device A (Test treatment, T)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the serum concentration time curve from time 0 (pre dose) extrapolated to infinity (AUC0-inf) in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose	In each Treatment Period pre-dose to 16 weeks post dose
Area under the serum concentration time curve from time 0 (pre dose) to time of last quantifiable concentration in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose.	In each Treatment Period pre-dose to 16 weeks post dose
Observed maximum serum concentration (Cmax) in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose	In each Treatment Period pre-dose to 16 weeks post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time corresponding to observed maximum serum concentration (tmax)		In each Treatment Period pre-dose to 16 weeks post dose
Terminal half life (t½) in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose		In each Treatment Period pre-dose to 16 weeks post dose
Apparent total body clearance (CL/F), calculated as dose/AUC0-inf	(AUC0-inf: Area under the serum concentration time curve from time 0 (pre dose) extrapolated to infinity)	In each Treatment Period pre-dose to 16 weeks post dose
Apparent volume of distribution based on terminal phase (Vz/F), calculated as t½/ln(2)*CL/F	(t½: Terminal half life; CL/F: Apparent total body clearance)	In each Treatment Period pre-dose to 16 weeks post dose
Number of treatment emergent adverse events (TEAEs) from Day 1 to Day 126 and of TEAEs from Day 127 to Day 239 (number of adverse events [AEs] emerging with each treatment)		Day 1 to Day 239
Presence of binding and neutralizing anti-drug antibodies (ADAs) at Days 1 (pre dose), 15, and 57 of Treatment Periods 1 and 2 and Day 239		Day 1 to Day 239

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): December 29, 2021
• Study Completion (Actual): December 29, 2021

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Antibodies, Monoclonal
• Other Study ID Numbers: LP0162-1491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data feasibility requests and research proposals are sent to disclosure@leo-pharma.com. If feasibility to share the data from a trial is granted, the ultimate decision is made by an external to the company board (Patient and Scientific Review Board). Data sharing is further subject to signed data sharing agreement. Data will be available in a closed environment for a specified period on time.
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes