A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma

The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.

Interleukin-13 (IL-13) is a pleiotropic cytokine that promotes inflammation, airways hyper-responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE) synthesis and mast cell activation.Tralokinumab (CAT-354) is a human immunoglobulin G4 (IgG4) anti-IL-13 monoclonal antibody that has been shown to potently and specifically neutralize IL-13 in preclinical models.This study will evaluate the PK profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the PK data from completed studies in adults.

Inclusion Criteria:

• Age 12-17 years (inclusive)
• Weight greater than (>) 30 kilogram (kg)
• Asthma for a minimum of 6 months prior to Screening
• Effective birth control for both male and female participants in line with protocol details.
• Exclusion Criteria:
• Previously taken tralokinumab (the study drug)
• Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
• Pregnant or breastfeeding women
• Current smoker or cessation less than (<) 3 months prior to screening
• Known immune deficiency excluding asymptomatic selective immunoglobulin A
• History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive
• Any disease which may cause complications whilst taking the study drug.