A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Tralokinumab administered as 2 × Y mL with Device B; Drug: Tralokinumab administered as 1 × X mL with Device A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04674826

LP0162-1491

Details and patient eligibility

About

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.

Full 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).

Enrollment: 101 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

TR (Test-Reference)

Experimental group

Description:

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)

Treatment:

Drug: Tralokinumab administered as 1 × X mL with Device A

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

RT (Reference-Test)

Experimental group

Description:

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)

Treatment:

Drug: Tralokinumab administered as 1 × X mL with Device A

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