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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tralokinumab 300 mg

Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.

Group Type EXPERIMENTAL

Tralokinumab 300 mg

Intervention Type BIOLOGICAL

Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

Interventions

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Tralokinumab 300 mg

Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

Intervention Type BIOLOGICAL

Other Intervention Names

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CAT-354

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No