Trial record 2 of 6 for:    medimmune tralokinumab

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01592396
First received: April 25, 2012
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Asthma
Biological: Cohort 1
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 22
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort 1
Active
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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592396

Locations
Poland
Research Site
Karpacz, Dolnośląskie, Poland
Research Site
Gdańsk, Pomorskie, Poland
Research Site
Łódź, Łódzkie, Poland
Research Site
Gliwice, Śląskie, Poland
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Edward Piper, MBBS MedImmune Ltd
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01592396     History of Changes
Other Study ID Numbers: CD-RI-CAT-354-1054, 2011-005503-33
Study First Received: April 25, 2012
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014