Study of Belimumab Administered Subcutaneously to Healthy Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in healthy subjects.

Detailed Description

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This study is designed to evaluate the absolute bioavailability, pharmacokinetics, tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of belimumab administered subcutaneously (SC) to healthy subjects.

Conditions

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Healthy

Keywords

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Belimumab Injections, Subcutaneous Drug Administration Routes Injections Lupus Erythematosus, Systemic Lupus SLE Systemic Lupus Erythematosus Antibodies Autoimmune Disease Biological Therapy Immune System Diseases Pharmacokinetics Biological Availability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belimumab IV 240 mg

Group Type ACTIVE_COMPARATOR

Single Dose Group: Belimumab IV 240 mg

Intervention Type BIOLOGICAL

Belimumab IV 240 mg administered on Day 0

Belimumab SC 2 x 120 mg

Group Type EXPERIMENTAL

Single Dose Group: Belimumab SC 2 x 120 mg

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

Single Dose Group: Belimumab SC 1 x 240 mg

Intervention Type BIOLOGICAL

Belimumab SC 240 mg x 1 injection on Day 0

Belimumab SC 1 x 200 mg

Group Type EXPERIMENTAL

Single Dose Group: Belimumab SC 1 x 200 mg

Intervention Type BIOLOGICAL

Belimumab SC 200 mg x 1 injection on Day 0

Belimumab SC 2 x 120 mg weekly

Group Type EXPERIMENTAL

Multiple Dose Group: Belimumab SC 2 x 120 mg weekly

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

Intervention Type BIOLOGICAL

Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21

Interventions

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Single Dose Group: Belimumab IV 240 mg

Belimumab IV 240 mg administered on Day 0

Intervention Type BIOLOGICAL

Single Dose Group: 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

Intervention Type BIOLOGICAL

Single Dose Group: Belimumab SC 1 x 240 mg

Belimumab SC 240 mg x 1 injection on Day 0

Intervention Type BIOLOGICAL

Single Dose Group: Belimumab SC 1 x 200 mg

Belimumab SC 200 mg x 1 injection on Day 0

Intervention Type BIOLOGICAL

Multiple Dose Group: 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

Intervention Type BIOLOGICAL

Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21

Intervention Type BIOLOGICAL

Other Intervention Names

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BENLYSTA™ BENLYSTA™ BENLYSTA™ BENLYSTA™ BENLYSTA™ BENLYSTA™

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects defined as no clinically relevant abnormalities identified by a detailed medical history, full physical exam, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
* Body weight between 45 to 120 kg (99 to 264 lbs).
* Must agree to use effective contraception throughout the study and for 14 weeks after administration of belimumab.
* Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.

Exclusion Criteria

* Pregnant or nursing.
* Test positive for drugs or alcohol or have had a drug or alcohol dependence within the past year.
* Have used any prescription medicines within the past 30 days or herbal/botanical supplements within the past 7 days or anticipate use during the study. May use prescription contraceptives, hormone replacement therapy, and over-the-counter medicines such as antihistamines or nutritional support such as vitamins, minerals, or amino acids.
* Have received a live vaccine within the past 30 days or anticipate receipt of a live vaccine during the study and within 4 months after last injection of belimumab.
* Have a history of an allergic or anaphylactic reaction to drugs, food, or insect bite or sting requiring medical intervention.
* Have a history of allergic reaction to contrast agents or biological medicines.
* Have participated in a clinical trial and received an experimental medicine within the past 60 days.
* Have received treatment with a B cell targeted therapy at any time.
* Have required management of an infection within the past 14 days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Daytona Beach, Florida, United States

Site Status

Evansville, Indiana, United States

Site Status

Dallas, Texas, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

Reference Type DERIVED

PMID: 34741731 (View on PubMed)

Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.

Reference Type DERIVED

PMID: 34628605 (View on PubMed)

Other Identifiers

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HGS1006-C1105

Identifier Type: -

Identifier Source: org_study_id

Study of Belimumab Administered Subcutaneously to Healthy Subjects

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Belimumab IV 240 mg

Single Dose Group: Belimumab IV 240 mg

Belimumab SC 2 x 120 mg

Single Dose Group: Belimumab SC 2 x 120 mg

Belimumab SC 1 x 240 mg

Single Dose Group: Belimumab SC 1 x 240 mg

Belimumab SC 1 x 200 mg

Single Dose Group: Belimumab SC 1 x 200 mg

Belimumab SC 2 x 120 mg weekly

Multiple Dose Group: Belimumab SC 2 x 120 mg weekly

Belimumab SC 1 x 200 mg weekly

Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

Interventions

Single Dose Group: Belimumab IV 240 mg

Single Dose Group: Belimumab SC 2 x 120 mg

Single Dose Group: Belimumab SC 1 x 240 mg

Single Dose Group: Belimumab SC 1 x 200 mg

Multiple Dose Group: Belimumab SC 2 x 120 mg weekly

Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Human Genome Sciences Inc.

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

Countries

References

Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.

Other Identifiers

HGS1006-C1105