A Trial to Investigate the Pharmacokinetics of Tralokinumab in Adolescents, a Product Under Investigation for the Treatment of Asthma

Asthma Clinical Trial

— CAT354-1054  

Official title:

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592396
• Other study ID #: CD-RI-CAT-354-1054
• Secondary ID: 2011-005503-33
• Status: Completed
• Phase: Phase 1
• First received: April 25, 2012
• Last updated: May 22, 2013
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age 12-17 years (inclusive)

• Weight > 30kg

• Asthma for a minimum of 6 months

• 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 < 3 months

• Known immune deficiency

• History of cancer

• Hepatitis B, C or HIV

• Any disease which may cause complications whilst taking the study drug

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Cohort 1
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.

Locations

Country	Name	City	State
Poland	Research Site	Gdansk	Pomorskie
Poland	Research Site	Gliwice	Slaskie
Poland	Research Site	Karpacz	Dolnoslaskie
Poland	Research Site	Lódz	Lódzkie

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	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);	Day 1 - Day 57	Yes
Primary	Pharmacokinetics	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);	Day 1 - Day 57	Yes
Primary	Pharmacokinetics	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);	Day 1 - Day 57	Yes
Primary	Pharmacokinetics	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)	Day 1 - Day 57	Yes
Primary	Pharmacokinetics	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).	Day 1 - Day 57	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	To evaluate the saftey and tolerability of tralokinumab through monitoring of adverse event data from day 1 - day 57.	Day 1 - Day 57	Yes
Secondary	Safety and Tolerability through the measure of Immunogenicity	To evaluate the saftey and tolerability of tralokinumab through collection of immunogenicity samples to be tested for anti-drug antibodies	Day 1 - Day 57	Yes