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 Investigate the Pharmacokinetics of Tralokinumab (CAT-354) 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.