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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01592396
First received: April 25, 2012
Last updated: January 20, 2017
Last verified: January 2017
Results First Received: October 3, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Asthma
Intervention: Biological: Tralokinumab 300 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 30 participants were screened, out of which 20 were randomized into the study. The reasons for screen failures were not meeting the inclusion/exclusion criteria, and/or consent withdrawal.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2 Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

Participant Flow:   Overall Study
    Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1   Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.

Reporting Groups
  Description
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2 Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Total Total of all reporting groups

Baseline Measures
   Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1   Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.6  (0.7)   15.8  (0.9)   14.2  (1.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  30.0%      3  30.0%      6  30.0% 
Male      7  70.0%      7  70.0%      14  70.0% 


  Outcome Measures
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1.  Primary:   Time to Reach Maximum Observed Serum Concentration (Tmax)   [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]

2.  Primary:   Maximum Observed Serum Concentration (Cmax)   [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]

3.  Primary:   Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])   [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]

4.  Primary:   Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])   [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]

5.  Primary:   Terminal Phase Elimination Half Life (t1/2)   [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]

6.  Secondary:   Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)   [ Time Frame: Day 1 to Day 57 ]

7.  Secondary:   Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit   [ Time Frame: Day 1 and Day 57 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Dose-normalized AUC(0-infinity) and dose-normalized Cmax were not evaluated as they were not relevant for single-dose study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Meena Jain, MB BChir/Associate Medical Director
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: jainm@medimmune.com


Publications:

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01592396     History of Changes
Other Study ID Numbers: CD-RI-CAT-354-1054
2011-005503-33 ( EudraCT Number )
Study First Received: April 25, 2012
Results First Received: October 3, 2016
Last Updated: January 20, 2017