Asthma Clinical Trial
Official title:
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma
The pharmacokinetic (PK) profile of tralokinumab will be studied in adolescent subjects with asthma.
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 IgE synthesis and mast cell activation.Tralokinumab (CAT‐354) is a human 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 pharmacokinetic 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. ;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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