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Trial record 1 of 10 for:    CAT-354
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A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

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ClinicalTrials.gov Identifier: NCT00638989
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Asthma
Healthy
Interventions: Biological: CAT-354 150 mg (intravenous)
Biological: CAT-354 150 mg (subcutaneous)
Biological: CAT-354 300 mg (subcutaneous)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
CAT-354 150 mg (Intravenous) A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
CAT-354 150 mg (Subcutaneous) A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
CAT-354 300 mg (Subcutaneous) A single dose of CAT-354 300 mg injection subcutaneously on Day 0.

Participant Flow:   Overall Study
    CAT-354 150 mg (Intravenous)   CAT-354 150 mg (Subcutaneous)   CAT-354 300 mg (Subcutaneous)
STARTED   10   10   10 
COMPLETED   10   10   9 
NOT COMPLETED   0   0   1 
Lost to Follow-up                0                0                1 



  Baseline Characteristics

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.
Analysis population included all enrolled participants.

Reporting Groups
  Description
CAT-354 150 mg (Intravenous) A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
CAT-354 150 mg (Subcutaneous) A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
CAT-354 300 mg (Subcutaneous) A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Total Total of all reporting groups

Baseline Measures
   CAT-354 150 mg (Intravenous)   CAT-354 150 mg (Subcutaneous)   CAT-354 300 mg (Subcutaneous)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   10   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.4  (8.3)   39.3  (8.6)   27.8  (10.4)   32.5  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      10 100.0%      10 100.0%      10 100.0%      30 100.0% 


  Outcome Measures

1.  Primary:   Absolute Bioavailability of CAT-354 After Subcutaneous Dose   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

2.  Secondary:   Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)   [ Time Frame: Day 0 to 56 ]

3.  Secondary:   Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit   [ Time Frame: Day 0 and Day 56 ]

4.  Secondary:   Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

5.  Secondary:   Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

6.  Secondary:   Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

7.  Secondary:   Maximum Observed Serum Concentration (Cmax)   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

8.  Secondary:   Dose Normalized Maximum Observed Concentration (Cmax/Dose)   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

9.  Secondary:   Time to Reach Maximum Observed Serum Concentration (Tmax)   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

10.  Secondary:   Terminal Phase Elimination Half Life (t1/2)   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

11.  Secondary:   Apparent Systemic Clearance (CL/F) After Subcutaneous Dose   [ Time Frame: Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

12.  Secondary:   Apparent Systemic Clearance (CL/F) After Intravenous Dose   [ Time Frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]

13.  Secondary:   Volume of Distribution at Steady State (Vss) After Intravenous Infusion   [ Time Frame: Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT00638989     History of Changes
Other Study ID Numbers: CAT-354-0703
First Submitted: March 12, 2008
First Posted: March 19, 2008
Results First Submitted: March 22, 2017
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017