- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01583530
Study of Belimumab Administered Subcutaneously to Healthy Subjects
August 1, 2013 updated by: Human Genome Sciences Inc.
A Randomized, Parallel-Group, Open-Label Study to Evaluate the Absolute Bioavailability, Pharmacokinetics, Tolerability and Safety of a High Concentration Formulation of Belimumab (HGS1006), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Daytona Beach, Florida, United States
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Indiana
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Evansville, Indiana, United States
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Texas
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Dallas, Texas, United States
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Wisconsin
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Madison, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Key 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.
Key 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Belimumab IV 240 mg
|
Belimumab IV 240 mg administered on Day 0
Other Names:
|
Experimental: Belimumab SC 2 x 120 mg
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Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
Other Names:
|
Experimental: Belimumab SC 1 x 240 mg
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Belimumab SC 240 mg x 1 injection on Day 0
Other Names:
|
Experimental: Belimumab SC 1 x 200 mg
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Belimumab SC 200 mg x 1 injection on Day 0
Other Names:
|
Experimental: Belimumab SC 2 x 120 mg weekly
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Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
Other Names:
|
Experimental: Belimumab SC 1 x 200 mg weekly
|
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
|
|
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
|
Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
|
|
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
|
AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It is obtained from AUC (0-last) plus C (last)/λz.
C (last) is the last measurable concentration.
λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
|
Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
|
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
|
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
|
Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
|
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
|
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation.
The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.
|
Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
|
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
|
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
|
|
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
|
AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It is obtained from AUC (0-last) plus C (last)/λz.
C (last) is the last measurable concentration.
λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.
|
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
|
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
|
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
|
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
|
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
|
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation.
The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.
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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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Number of Participants Who Experienced Adverse Events
Time Frame: Up to Day 119
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Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
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Up to Day 119
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
April 20, 2012
First Submitted That Met QC Criteria
April 23, 2012
First Posted (Estimate)
April 24, 2012
Study Record Updates
Last Update Posted (Estimate)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 1, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HGS1006-C1105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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