Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00116168
First received: June 27, 2005
Last updated: October 17, 2013
Last verified: October 2013
Results First Received: October 17, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Biological: MEDI-528 0.3 mg/kg
Biological: MEDI-528 1 mg/kg
Biological: MEDI-528 3 mg/kg
Biological: MEDI-528 9 mg/kg

  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 29 participants provided written informed consent and participated in the study at 2 sites in the United States of America between 10Jun2005 and 18Apr2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants received MEDI-528 in an open-label manner.

Reporting Groups
  Description
MEDI-528 0.3 mg No text entered.
MEDI-528 1 mg No text entered.
MEDI-528 3 mg No text entered.
MEDI-528 9 mg No text entered.

Participant Flow:   Overall Study
    MEDI-528 0.3 mg     MEDI-528 1 mg     MEDI-528 3 mg     MEDI-528 9 mg  
STARTED     6     11     6     6  
COMPLETED     0     6     6     6  
NOT COMPLETED     6     5     0     0  
Lost to Follow-up                 6                 5                 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.
No text entered.

Reporting Groups
  Description
MEDI-528 0.3 mg No text entered.
MEDI-528 1 mg No text entered.
MEDI-528 3 mg No text entered.
MEDI-528 9 mg No text entered.
Total Total of all reporting groups

Baseline Measures
    MEDI-528 0.3 mg     MEDI-528 1 mg     MEDI-528 3 mg     MEDI-528 9 mg     Total  
Number of Participants  
[units: participants]
  6     11     6     6     29  
Age  
[units: Years]
Mean ± Standard Deviation
  27.2  ± 8.7     25.2  ± 9.7     34.7  ± 7.8     33.2  ± 13.9     29.2  ± 10.5  
Gender  
[units: Participants]
         
Female     4     4     3     3     14  
Male     2     7     3     3     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Adverse Events   [ Time Frame: Days 0 - 84 ]

2.  Primary:   Incidence of Abnormal Troponin Levels   [ Time Frame: Days 0, 1, 7, 14, and 28 ]

3.  Primary:   Incidence of Clinically Significant Changes From Baseline in Neurologic Exam   [ Time Frame: Days 0, 7, 14, 21, 28, 42, and 84 ]

4.  Primary:   Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain   [ Time Frame: Days 0 and 28 ]

5.  Primary:   Incidence of Serious Adverse Events   [ Time Frame: Days 0 - 84 ]

6.  Secondary:   Incidence of Anti-drug Antibodies (ADA) to MEDI-528   [ Time Frame: Days 0, 14, 28, 42, and 84 ]

7.  Secondary:   Time to Observed Maximum Serum Concentration (Tmax)   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]

8.  Secondary:   Observed Maximum Serum Concentration (Cmax)   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]

9.  Secondary:   Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]

10.  Secondary:   Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]

11.  Secondary:   Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]

12.  Secondary:   Total Body Clearance (CL)   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]

13.  Secondary:   Half-life (T1/2)   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]

14.  Secondary:   Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)   [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Don Raible, MD
Organization: MedImmune
phone: 301-398-0000
e-mail: raibleD@medimmune.com


No publications provided


Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00116168     History of Changes
Other Study ID Numbers: MI-CP109
Study First Received: June 27, 2005
Results First Received: October 17, 2013
Last Updated: October 17, 2013
Health Authority: United States: Food and Drug Administration