Study of Belimumab Administered Subcutaneously to Healthy Subjects

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

ClinicalTrials.gov Identifier:

NCT01583530

First received: April 20, 2012

Last updated: October 29, 2012

Last verified: October 2012

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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 ]

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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 ]

Show Outcome Measure 2

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 ]

Show Outcome Measure 3

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 ]

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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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

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 ]

Show Outcome Measure 9

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 ]

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11. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: For multi-center trials, no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review at least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months.

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
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
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:	October 29, 2012
Health Authority:	United States: Food and Drug Administration

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