HealthyPhase 1NCT01583530

Study of Belimumab Administered Subcutaneously to Healthy Subjects

A Phase 1 study testing Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg and Single Dose Group: Belimumab SC 1 x 240 mg in people with Healthy, run by Human Genome Sciences Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg and Single Dose Group: Belimumab SC 1 x 240 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 4 sitesUnited States
Study dates: Feb 2011to Sep 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Dallas, Texas
Study site
Daytona Beach, Florida
Study site
Evansville, Indiana
Study site
Madison, Wisconsin

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Healthy
Being tested: 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
Keywords: 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
Medical subject headings: Lupus Erythematosus, Systemic, Autoimmune Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single Dose Group: Belimumab IV 240 mgBiological
Also called BENLYSTA™
Belimumab IV 240 mg administered on Day 0
Single Dose Group: Belimumab SC 2 x 120 mgBiological
Also called BENLYSTA™
Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
Single Dose Group: Belimumab SC 1 x 240 mgBiological
Also called BENLYSTA™
Belimumab SC 240 mg x 1 injection on Day 0
Single Dose Group: Belimumab SC 1 x 200 mgBiological
Also called BENLYSTA™
Belimumab SC 200 mg x 1 injection on Day 0
Multiple Dose Group: Belimumab SC 2 x 120 mg weeklyBiological
Also called BENLYSTA™
Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
Multiple Dose Group: Belimumab SC 1 x 200 mg weeklyBiological
Also called BENLYSTA™
Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21

Study groups in NCT01583530
Study group	Role	What they receive
Belimumab IV 240 mg	Active comparator	Not described Receives: Biological: Single Dose Group: Belimumab IV 240 mg
Belimumab SC 2 x 120 mg	Experimental	Not described Receives: Biological: Single Dose Group: Belimumab SC 2 x 120 mg
Belimumab SC 1 x 240 mg	Experimental	Not described Receives: Biological: Single Dose Group: Belimumab SC 1 x 240 mg
Belimumab SC 1 x 200 mg	Experimental	Not described Receives: Biological: Single Dose Group: Belimumab SC 1 x 200 mg
Belimumab SC 2 x 120 mg weekly	Experimental	Not described Receives: Biological: Multiple Dose Group: Belimumab SC 2 x 120 mg weekly
Belimumab SC 1 x 200 mg weekly	Experimental	Not described Receives: Biological: Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)
Measured: 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
Measured: 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
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.
Measured: 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
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
Measured: 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
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.
Measured: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

Secondary outcomes (6)

Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab
Measured: 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
Measured: 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
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.
Measured: 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
Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.
Measured: 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
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.
Measured: 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
Number of Participants Who Experienced Adverse Events
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).
Measured: Up to Day 119

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Sep 2011

First posted24 Apr 2012 (estimated)
Study startFeb 2011
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01583530
Sponsor's protocol ID: HGS1006-C1105
Status last verified: Aug 2013
First submitted: 20 Apr 2012
Last updated: 7 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 34741731
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.
PubMed 34628605

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01583530
Acronym / sponsor ID: HGS1006-C1105
Conditions: Healthy
Keywords: Belimumab, Injections, Subcutaneous, Drug Administration Routes, Injections, Lupus Erythematosus, Systemic, Lupus, SLE, Systemic Lupus Erythematosus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Human Genome Sciences Inc.Industry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Feb 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 24 Apr 2012 (estimated)
Results: Posted 28 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Belimumab IV 240 mg	Active comparator	Biological: Single Dose Group: Belimumab IV 240 mg
Belimumab SC 2 x 120 mg	Experimental	Biological: Single Dose Group: Belimumab SC 2 x 120 mg
Belimumab SC 1 x 240 mg	Experimental	Biological: Single Dose Group: Belimumab SC 1 x 240 mg
Belimumab SC 1 x 200 mg	Experimental	Biological: Single Dose Group: Belimumab SC 1 x 200 mg
Belimumab SC 2 x 120 mg weekly	Experimental	Biological: Multiple Dose Group: Belimumab SC 2 x 120 mg weekly
Belimumab SC 1 x 200 mg weekly	Experimental	Biological: Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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 (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Single Dose Group: Belimumab IV 240 mgAlso: BENLYSTA™Belimumab IV 240 mg administered on Day 0	Biological	Belimumab IV 240 mg
Single Dose Group: Belimumab SC 2 x 120 mgAlso: BENLYSTA™Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0	Biological	Belimumab SC 2 x 120 mg
Single Dose Group: Belimumab SC 1 x 240 mgAlso: BENLYSTA™Belimumab SC 240 mg x 1 injection on Day 0	Biological	Belimumab SC 1 x 240 mg
Single Dose Group: Belimumab SC 1 x 200 mgAlso: BENLYSTA™Belimumab SC 200 mg x 1 injection on Day 0	Biological	Belimumab SC 1 x 200 mg
Multiple Dose Group: Belimumab SC 2 x 120 mg weeklyAlso: BENLYSTA™Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21	Biological	Belimumab SC 2 x 120 mg weekly
Multiple Dose Group: Belimumab SC 1 x 200 mg weeklyAlso: BENLYSTA™Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21	Biological	Belimumab SC 1 x 200 mg weekly

Primary outcome

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
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
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.
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.
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.

6 secondary outcomes

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
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
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
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
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
Number of Participants Who Experienced Adverse Events
Time frame: Up to Day 119

Results and safety

Results posted to the registry on 28 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Belimumab IV 240 mg	19	19
Belimumab SC 2 x 120 mg	20	17
Belimumab SC 1 x 240 mg	20	20
Belimumab SC 1 x 200 mg	19	18
Belimumab SC 2 x 120 mg Weekly	20	15
Belimumab SC 1 x 200 mg Weekly	20	17

Primary outcome: 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. Median (Full Range). Unit: days

Measure	Belimumab IV 240 mg n = 19	Belimumab SC 2 x 120 mg n = 19	Belimumab SC 1 x 240 mg n = 18	Belimumab SC 1 x 200 mg n = 18
Value	0.09 (0.05 to 0.30)	3.9 (0.9 to 9.8)	4.9 (2.9 to 13.9)	5.9 (1.9 to 13.9)

Population analysed: The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: µg/mL

Measure	Belimumab IV 240 mg n = 19	Belimumab SC 2 x 120 mg n = 19	Belimumab SC 1 x 240 mg n = 18	Belimumab SC 1 x 200 mg n = 18
Value	86.2 (20.0)	32.7 (29.0)	31.6 (27.9)	24.3 (40.3)

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: µg∙day/mL

Measure	Belimumab IV 240 mg n = 19	Belimumab SC 2 x 120 mg n = 19	Belimumab SC 1 x 240 mg n = 18	Belimumab SC 1 x 200 mg n = 18
Value	1030 (32.1)	788 (36.1)	812 (36.2)	612 (37.9)

Primary outcome: 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. Mean (Standard Deviation). Unit: days

Measure	Belimumab IV 240 mg n = 19	Belimumab SC 2 x 120 mg n = 19	Belimumab SC 1 x 240 mg n = 18	Belimumab SC 1 x 200 mg n = 18
Value	18.2 (6.3)	15.9 (5.3)	18.2 (6.0)	16.0 (5.1)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Day 119. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belimumab IV 240 mg	0 of 19 (0%)	14 of 19 (73.7%)	Not reported
Belimumab SC 2 x 120 mg	0 of 20 (0%)	11 of 20 (55%)	Not reported
Belimumab SC 1 x 240 mg	0 of 20 (0%)	16 of 20 (80%)	Not reported
Belimumab SC 1 x 200 mg	0 of 19 (0%)	14 of 19 (73.7%)	Not reported
Belimumab SC 2 x 120 mg Weekly	1 of 20 (5%)	17 of 20 (85%)	Not reported
Belimumab SC 1 x 200 mg Weekly	1 of 20 (5%)	19 of 20 (95%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34741731Gupta 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.
Derived from this study: PubMed 34628605Zhou 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01583530, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.