A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects

NCT04674826 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: LP0162-1491
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

  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

  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

Study Arms (2)

TR (Test-Reference)

EXPERIMENTAL

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; Device: Tralokinumab administered as 2 × Y mL with Device B

RT (Reference-Test)

EXPERIMENTAL

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; Device: Tralokinumab administered as 2 × Y mL with Device B

Interventions

Tralokinumab administered as 1 × X mL with Device A DRUG

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

RT (Reference-Test); TR (Test-Reference)

Tralokinumab administered as 2 × Y mL with Device B DEVICE

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

RT (Reference-Test); TR (Test-Reference)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Pharma Investigational Site

Berlin, 14050, Germany

Location

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: February 8, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: April 24, 2026

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)