Study of Belimumab Administered Subcutaneously to Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT01583530
First received: April 20, 2012
Last updated: August 1, 2013
Last verified: August 2013
Results First Received: May 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Biological: Single Dose Group: Belimumab IV 240 mg
Biological: Single Dose Group: Belimumab SC 2 x 120 mg
Biological: Single Dose Group: Belimumab SC 1 x 240 mg
Biological: Single Dose Group: Belimumab SC 1 x 200 mg
Biological: Multiple Dose Group: Belimumab SC 2 x 120 mg weekly
Biological: Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

  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
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
Belimumab IV 240 mg Belimumab IV 240 mg administered on Day 0
Belimumab SC 2 x 120 mg Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
Belimumab SC 1 x 240 mg Belimumab SC 240 mg x 1 injection on Day 0
Belimumab SC 1 x 200 mg Belimumab SC 200 mg x 1 injection on Day 0
Belimumab SC 2 x 120 mg Weekly Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
Belimumab SC 1 x 200 mg Weekly Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21

Participant Flow:   Overall Study
    Belimumab IV 240 mg     Belimumab SC 2 x 120 mg     Belimumab SC 1 x 240 mg     Belimumab SC 1 x 200 mg     Belimumab SC 2 x 120 mg Weekly     Belimumab SC 1 x 200 mg Weekly  
STARTED     19     20     20     19     20     20  
COMPLETED     19     17     20     18     15     17  
NOT COMPLETED     0     3     0     1     5     3  
Adverse Event                 0                 0                 0                 0                 0                 1  
Withdrawal by Subject                 0                 3                 0                 1                 1                 2  
Lost to Follow-up                 0                 0                 0                 0                 3                 0  
Lack of compliance                 0                 0                 0                 0                 1                 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
Belimumab IV 240 mg Belimumab IV 240 mg administered on Day 0
Belimumab SC 2 x 120 mg Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
Belimumab SC 1 x 240 mg Belimumab SC 240 mg x 1 injection on Day 0
Belimumab SC 1 x 200 mg Belimumab SC 200 mg x 1 injection on Day 0
Belimumab SC 2 x 120 mg Weekly Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
Belimumab SC 1 x 200 mg Weekly Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
Total Total of all reporting groups

Baseline Measures
    Belimumab IV 240 mg     Belimumab SC 2 x 120 mg     Belimumab SC 1 x 240 mg     Belimumab SC 1 x 200 mg     Belimumab SC 2 x 120 mg Weekly     Belimumab SC 1 x 200 mg Weekly     Total  
Number of Participants  
[units: participants]
  19     20     20     19     20     20     118  
Age  
[units: years]
Mean ± Standard Deviation
  37.3  ± 12.1     33.4  ± 11.4     35.2  ± 12.1     36.1  ± 9.4     33.7  ± 9.5     37.4  ± 9.7     35.5  ± 10.7  
Gender  
[units: participants]
             
Female     12     13     11     8     11     10     65  
Male     7     7     9     11     9     10     53  
Region of Enrollment  
[units: participants]
             
United States     19     20     20     19     20     20     118  



  Outcome Measures
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1.  Primary:   Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 ]

2.  Primary:   Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 ]

3.  Primary:   Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 ]

4.  Primary:   Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 ]

5.  Primary:   Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 ]

6.  Secondary:   Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 ]

7.  Secondary:   Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 ]

8.  Secondary:   Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 ]

9.  Secondary:   Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 ]

10.  Secondary:   Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab   [ Time Frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 ]

11.  Secondary:   Number of Participants Who Experienced Adverse Events   [ Time Frame: Up to Day 119 ]


  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
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  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT01583530     History of Changes
Other Study ID Numbers: HGS1006-C1105
Study First Received: April 20, 2012
Results First Received: May 22, 2012
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration