A Trial to Investigate the Pharmacokinetics of Tralokinumab in Adolescents, a Product Under Investigation for the Treatment of Asthma (CAT354-1054)

• Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
  Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation (AUC(0-infinity); AUC(0-t)); dose-normalized AUC(0-infinity) (AUC(0-infinity)/D);
  
  
• Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
  Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation Cmax; dose-normalized Cmax (Cmax/D); time to Cmax (Tmax);
  
  
• Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
  Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation dose-normalized terminal-phase elimination half-life (t1/2);
  
  
• Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
  Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation apparent clearance (CL/F)
  
  
• Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
  Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation steady-state volume of distribution (Vss/F).
  
  

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
  To evaluate the saftey and tolerability of tralokinumab through monitoring of adverse event data from day 1 - day 57.
  
  
• Safety and Tolerability through the measure of Immunogenicity [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
  To evaluate the saftey and tolerability of tralokinumab through collection of immunogenicity samples to be tested for anti-drug antibodies
  
  

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.