Systemic Lupus ErythematosusPhase 1NCT01894360
A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects
A Phase 1 study testing Belimumab 200 mg/mL in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects using a prefilled syringe or autoinjector. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Belimumab 200 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2013to 13 May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female aged between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied, may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Negative urine drug screen; A negative urine drug screen for ethanol, opioids, barbiturates, cocaine, and amphetamines is required during screening
- Body weight >=45 kilograms (kg) to 120 kg (inclusive) at Screening
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy (for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records); or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] >40 milli international units/milliliter (MlU/ml) and estradiol <40 picogram/milliliter (pg/ml) (<147 picomol/liter [pmol/L]) is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential with negative pregnancy test as determined by serum or urine human chorionic gonadotropins (hCG) test at screening or prior to dosing and Agrees to use one of the contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until Day 112, or; OR has only same-sex partners, when this is her preferred and usual lifestyle.
- Alanine aminotransferase (ALT), alkaline phosphatase (ALP) and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QTc <450 milliseconds (msec), QTc <480 msec in subjects with bundle branch block.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- The use of any concomitant prescription medications within the 30 days prior to Day 0, or anticipated use during the study period. Subjects taking prescription contraceptives, HRT, over the counter medications (e.g., antihistamines), or nutritional support (vitamins, minerals, or amino acids) may be enrolled.
- Have received a live vaccine within 30 days of Day 0 or anticipate receipt of a live vaccine during the study or within 120 days after last injection of study drug.
- History of major organ transplant: e.g., heart, lung, kidney, liver, or hematopoietic stem cell transplant.
- History of malignant neoplasm within the last 5 years, except for adequately treated basal or squamous cell cancers of the skin, or carcinoma in situ of the uterine cervix.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study defined as: For UK sites: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. For US sites: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
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- History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- History of atopy or anaphylactic reaction to any food, drug, or insect bite/sting.
- History of allergic reaction to parenteral administration of contrast agents, foreign proteins, or monoclonal antibodies.
- History of any infection requiring hospitalization, antivirals, or antibiotics within 4 weeks prior to Day 0.
- History of or positive test for human immunodeficiency virus (HIV) at Screening.
- Grade 3 or 4 lymphopenia at Screening.
- A positive pre-study Hepatitis B surface antigen, or Hepatitis B core antibody or positive Hepatitis C antibody result within 3 months of screening.
- Grade 3/4 immunoglobulin G (IgG) deficiency and immunoglobulin A (IgA) deficiency at Screening.
- Participated in a clinical trial (ie, received the last dose) of an investigational agent within 30 days prior to screening or 5 half-lives of the drug (whichever is longer), or continues to show evidence of toxicity from an investigational agent taken during a clinical trial.
- Exposure to more than four new chemical entities within 12 months prior to Day 0.
- Received treatment with any B cell targeted therapy (eg, rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc, LY2127399 [anti-BAFF], belimumab or any other B cell depletor) at any time in the past.
- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
- Donated blood or have had a significant blood loss (volume ≥ 500 mL) within 56 days prior to screening. Donated plasma within 7 days prior to screening.
- Lactating females.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or Autoinjector
This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects using a prefilled syringe or autoinjector. This study will also assess the usability and reliability of the injection devices. A total of approximately 80 subjects (40 per group) will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0 milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned injection device. Subjects will continue to be followed for 70 days after the administration of belimumab.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Belimumab 200 mg/mL
- Keywords
- Pharmacokinetics, Phase 1, Healthy Subjects, Comparability, Belimumab
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belimumab 200 mg/mLDrug
Clear to opalescent, colorless to pale yellow sterile solution sterile solution for SC injection in a single-use liquid formulation of Belimumab 200 mg/mL will be supplied in 1mL long glass prefilled syringe or autoinjector device.
| Study group | Role | What they receive |
|---|---|---|
| Belimumab 200 mg/mL, prefilled syringe | Experimental | Subjects will be randomly assigned in a 1 to 1 ratio to receive a single dose of 200 mg belimumab SC (1.0 mL injection) via prefilled syringe on Day 0. Receives: Drug: Belimumab 200 mg/mL |
| Belimumab 200 mg/mL, Autoinjector | Experimental | Subjects will be randomly assigned in a 1 to 1 ratio to receive a single dose of 200 mg belimumab SC (1.0 mL injection) via prefilled syringe contained within an autoinjector device on Day 0. Receives: Drug: Belimumab 200 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK assessment for Cmax, AUC(0-t), AUC(0-inf)
Blood sample will be collected for estimation of relative bioavailability and assessment of PK parameters including maximum observed concentration; Cmax, area under the concentration-time curve from time 0 to time t; AUC(0-t) and area under the concentration-time curve from time 0 to infinity; AUC(0-inf)
Measured: From Baseline upto Day 70
Secondary outcomes (1)
Safety and tolerability assessment including Adverse events (AEs), serious adverse events (SAEs), changes in laboratory values, and vital signs
Safety measurements will be assessed for AEs and SAEs, clinical laboratory parameters including Clinical hematology, chemistry, serum immunoglobulin isotypes and urinalysis. Vital signs measurements including temperature, systolic and diastolic blood pressure, pulse rate and respiratory rate.
Measured: From Screening upto Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start14 Oct 2013
- Primary completion13 May 2014
- Study completion13 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894360
- Sponsor's protocol ID
- 117100
- Status last verified
- May 2017
- First submitted
- 3 Jul 2013
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or Autoinjector
- ClinicalTrials.gov ID
- NCT01894360
- Acronym / sponsor ID
- 117100
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Pharmacokinetics, Phase 1, Healthy Subjects, Comparability, Belimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2013 (actual)
- Primary completion
- 13 May 2014 (actual)
- Study completion
- 13 May 2014 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects using a prefilled syringe or autoinjector. This study will also assess the usability and reliability of the injection devices. A total of approximately 80 subjects (40 per group) will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0 milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned injection device. Subjects will continue to be followed for 70 days after the administration of belimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belimumab 200 mg/mL, prefilled syringe | Experimental | Drug: Belimumab 200 mg/mLSubjects will be randomly assigned in a 1 to 1 ratio to receive a single dose of 200 mg belimumab SC (1.0 mL injection) via prefilled syringe on Day 0. |
| Belimumab 200 mg/mL, Autoinjector | Experimental | Drug: Belimumab 200 mg/mLSubjects will be randomly assigned in a 1 to 1 ratio to receive a single dose of 200 mg belimumab SC (1.0 mL injection) via prefilled syringe contained within an autoinjector device on Day 0. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female aged between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied, may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Negative urine drug screen; A negative urine drug screen for ethanol, opioids, barbiturates, cocaine, and amphetamines is required during screening
- Body weight >=45 kilograms (kg) to 120 kg (inclusive) at Screening
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy (for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records); or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] >40 milli international units/milliliter (MlU/ml) and estradiol <40 picogram/milliliter (pg/ml) (<147 picomol/liter [pmol/L]) is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential with negative pregnancy test as determined by serum or urine human chorionic gonadotropins (hCG) test at screening or prior to dosing and Agrees to use one of the contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until Day 112, or; OR has only same-sex partners, when this is her preferred and usual lifestyle.
Key exclusion criteria (20 listed)
- The use of any concomitant prescription medications within the 30 days prior to Day 0, or anticipated use during the study period. Subjects taking prescription contraceptives, HRT, over the counter medications (e.g., antihistamines), or nutritional support (vitamins, minerals, or amino acids) may be enrolled.
- Have received a live vaccine within 30 days of Day 0 or anticipate receipt of a live vaccine during the study or within 120 days after last injection of study drug.
- History of major organ transplant: e.g., heart, lung, kidney, liver, or hematopoietic stem cell transplant.
- History of malignant neoplasm within the last 5 years, except for adequately treated basal or squamous cell cancers of the skin, or carcinoma in situ of the uterine cervix.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 |
|---|---|---|
| Belimumab 200 mg/mLClear to opalescent, colorless to pale yellow sterile solution sterile solution for SC injection in a single-use liquid formulation of Belimumab 200 mg/mL will be supplied in 1mL long glass prefilled syringe or autoinjector device. | Drug | Belimumab 200 mg/mL, Autoinjector, Belimumab 200 mg/mL, prefilled syringe |
Primary outcome
Plasma PK assessment for Cmax, AUC(0-t), AUC(0-inf)
Time frame: From Baseline upto Day 70
Blood sample will be collected for estimation of relative bioavailability and assessment of PK parameters including maximum observed concentration; Cmax, area under the concentration-time curve from time 0 to time t; AUC(0-t) and area under the concentration-time curve from time 0 to infinity; AUC(0-inf)
1 secondary outcome
Safety and tolerability assessment including Adverse events (AEs), serious adverse events (SAEs), changes in laboratory values, and vital signs
Time frame: From Screening upto Day 70
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Results for study 117100 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belimumab 200 mg/mL in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in United States.
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 8 inclusion and 20 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma PK assessment for Cmax, AUC(0-t), AUC(0-inf) (time frame: From Baseline upto Day 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.