Clinical trial NCT01592396: A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma
Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Tralokinumab
CAT-354
Asthma
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Reach Maximum Observed Serum Concentration (Tmax)
timeFrame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
measure: Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
timeFrame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
measure: Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
timeFrame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
measure: Terminal Phase Elimination Half Life (t1/2)
timeFrame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Secondary outcomes:
measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 to Day 57
measure: Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
timeFrame: Day 1 and Day 57
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Research Site
city: Karpacz
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
Study officials:
affiliation: MedImmune Ltd
name: Edward Piper, MBBS
role: STUDY_DIRECTOR
References:
citation: Baverel PG, Jain M, Stelmach I, She D, Agoram B, Sandbach S, Piper E, Kuna P. Pharmacokinetics of tralokinumab in adolescents with asthma: implications for future dosing. Br J Clin Pharmacol. 2015 Dec;80(6):1337-49. doi: 10.1111/bcp.12725. Epub 2015 Oct 1.