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Systemic Lupus ErythematosusPhase 1NCT04136145

Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects

A Phase 1 study testing Belimumab for IV and Belimumab for SC in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in China.

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

This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab, administered either intravenously or subcutaneously via auto-injector. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Belimumab for IV and Belimumab for SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
28 Oct 2019to 14 Jan 2020
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
  • Chinese healthy male or female between 18 and 45 years of age inclusive, at the time of signing the informed consent.
  • Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. 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 GlaxoSmithKline (GSK) medical monitor if necessary) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Non-smoker or ex-smoker having ceased smoking for at least 6 months.
  • Body weight >=45.0 kilograms (kg) for females, >=50.0 kg for males, and body mass index (BMI) within the range 19.0<= to <=26.0 kilograms per meter square (kg/m^2).
  • Both male and female subjects are eligible to participate.
  • A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of belimumab.

Who cannot join

  • A positive test for syphilis, positive Hepatitis C antibody, human immune deficiency syndrome (HIV) antigen/antibody, at Screening. For Hepatitis B: subjects with a positive hepatitis B surface antigen (HbsAg) and/or a positive anti-hepatitis B core (HBc) result will be excluded.
  • A positive result of pre-study drug screen (including at minimum: amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines).
  • ALT or AST >1.2 times upper limit of normal (ULN).
  • Bilirubin >1.2 times ULN (isolated bilirubin >1.2 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • QTc >450 milliseconds (msec) based on single ECG. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine read or manually over-read.
  • Immunoglobulin (M, A, G) level is <Lower limit of normal (LLN) at Screening.
Show all 25Show fewer
  • 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 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.
  • Subjects with a sitting position systolic blood pressure <90 millimeters of mercury (mmHg) or >=140 mmHg and/or a sitting diastolic blood pressure <50 mmHg or >=90 mmHg and/or systolic blood pressure drop from supine to standing of >30 mmHg.
  • Symptomatic herpes zoster within 3 months prior to Screening.
  • Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posteroanterior) and a positive (not indeterminate) QuantiFERON-TB Gold test.
  • History of any infection requiring hospitalization or treatment with antivirals, antibiotics, anti-fungals, anti-parasitic agents or vaccination within 30 days prior to the administration of study medication.
  • History of regular alcohol consumption exceeding, on an average, 14 drinks/week for men or 7 drinks/week for female (1 drink = 5 ounces [150 mL] of wine or 350 mL of beer or 1.5 ounces [45 mL] of 80 proof distilled spirits) within 6 months of Screening.
  • The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months or 5 half-lives (whichever is longer) preceding the administration of study medication of this study.
  • Exposure to more than 4 new chemical entities within 12 months prior to the dosing day.
  • The subject planned to concurrently participate in another clinical study or post marketing study.
  • Use of any prescription or non-prescription medications including vitamins, herbal and dietary supplements within the 14 days or 5 half-lives (whichever is longer) prior to the administration of study medication.
  • History of B cell targeted therapy (rituximab, other anti-cluster of differentiation (CD)20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], B lymphocyte stimulator (BlyS)-receptor fusion protein [BR3], Transmembrane activator and calcium-modulator and cytophilin ligand interactor (TACI)-fusion (Fc), LY2127399 [anti-B cell-activating factor receptor (BAFF)] or belimumab) at any time.
  • Have received a live vaccine within 30 days of Day 1 or anticipate receipt of a live vaccine during the study or within 120 days after the last dose administration of study drug.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy (excluding pollen allergy) without current symptoms.
  • History of 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.
  • Donation of blood or blood products or significant blood loss in excess of 400 mL within 4 months or 200 mL within 2 months prior to administration
  • Subject is mentally or legally incapacitated, or unwillingness or inability (including mentally or legally incapacity) to follow the procedures outlined in the protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

  • GSK Investigational Site

    Shanghai, 201508

Other trials in China

About this study

Official title: An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Participants

This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab, administered either intravenously or subcutaneously via auto-injector. Each subject will be randomized in a 1:2 ratio to receive a single dose of either intravenous (IV) or subcutaneous (SC) administration of belimumab 200 mg. The total study duration will be approximately 13 weeks.

Being tested
Belimumab for IV, Belimumab for SC
Keywords
belimumab, Chinese, intravenous, subcutaneous, auto-injector
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 for IVDrug

    Belimumab will be available as white to off-white lyophilized cake at a unit dose strength of 400 mg to be reconstituted and diluted in normal saline to obtain 200 mg per dose.

  • Belimumab for SCDrug

    Belimumab will be available as clear to opalescent, colorless to pale yellow sterile solution at unit dose strength of 200 mg/milliliter (mg/mL) for SC injection in a single-use, prefilled syringe contained within an auto-injector device.

Study groups in NCT04136145
Study groupRoleWhat they receive
Belimumab SCExperimentalSubjects will be administered a single dose of belimumab 200 mg via the SC route. The dose will be administered in the front of the thigh via auto-injector device.
Receives: Drug: Belimumab for SC
Belimumab IVExperimentalSubjects will be administered a single dose of belimumab 200 mg via the IV route administered over approximately 1 hour.
Receives: Drug: Belimumab for IV

What is being measured

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

  1. Serum Concentration of Belimumab Following Intravenous Administration

    Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following intravenous administration. Pharmacokinetic Population comprised of all safety participants (all randomized participants who received at least one dose of study treatment) for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.

    Measured: Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion

  2. Serum Concentration of Belimumab Following Subcutaneous Administration

    Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following subcutaneous administration.

    Measured: Pre-dose and at 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 240 hours, 336 hours, 504 hours, 672 hours, 1008 hours, 1344 hours and 1680 hours post-dose

Secondary outcomes (7)

  1. Number of Participants With Abnormal Vital Signs

    Vital signs were measured in a semi-supine position after five minutes of rest and included tympanic temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The normal ranges were: temperature (35.0-38.0 degrees celsius), SBP (85-160 millimeters of mercury [mmHg]), DBP (45-100 mmHg), heart rate (60-90 beats per minute). Number of participants with abnormality in any vital signs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.

    Measured: Up to Day 71

  2. Number of Participants With Abnormal Electrocardiogram (ECG) Findings

    Twelve-lead ECGs were recorded with the participants in a semi-supine position, after 5 minutes of rest using an ECG machine. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with clinically significant and not clinically significant abnormal ECG findings have been presented.

    Measured: Up to Day 71

  3. Number of Participants With Abnormal Clinical Chemistry Parameters

    Blood samples were collected for the assessment of clinical chemistry parameters. The normal ranges were: alanine aminotransferase(7-40 international units per liter[IU/L]), albumin(40-55 grams per liter[g/L]), alkaline phosphatase(35-100 IU/L), amylase(25-125 units per liter), aspartate aminotransferase(13-35 IU/L), bilirubin(Bil.)(3.4-20.5 micromoles per liter [µmol/L]), calcium(2.1-2.55 millimoles per liter[mmol/L]), chloride(99-110 mmol/L), cholesterol(Chol.)(0-5.17 mmol/L), creatine kinase(29-168 IU/L), creatinine(41-73 µmol/L), direct Bil.(0-8.6 µmol/L), gamma glutamyl transferase(7-45 IU/L), glucose(3.9-6.1 mmol/L), high density Chol.(1.04-1.55 mmol/L), low density Chol.(2.59-4.11 mmol/L), lactate dehydrogenase(120-250 IU/L), phosphate(0.74-1.52 mmol/L), potassium(3.5-5.3 mmol/L), protein(65-85 g/L), sodium(137-147 mmol/L), triglycerides(0-1.69 mmol/L), urate(150-350 µmol/L), urea(2.6-7.5 mmol/L). Number of participants with abnormal clinical chemistry parameters are presented.

    Measured: Up to Day 71

  4. Number of Participants With Abnormal Hematology Parameters

    Blood samples were collected for the assessment of hematology parameters. The normal ranges for the parameters were: basophil count ([0.00-0.06]*10^9 cells per liter [cells/L]), eosinophil count ([0.02-0.52]*10^9 cells/L), erythrocyte count ([3.8-5.1]*10^12 cells/L), hematocrit (0.35-0.45 proportion of red blood cells in blood), hemoglobin (115-150 g/L), leukocyte count ([3.5-9.5]*10^9 cells/L), lymphocyte count ([1.1-3.2]*10^9 cells/L), monocyte count ([0.1-0.6]*10^9 cells/L), neutrophil count ([1.8-6.3]*10^9 cells/L), platelet count ([125-350]*10^9 cells/L). Number of participants with abnormal hematology parameters are presented.

    Measured: Up to Day 71

  5. Number of Participants With Abnormal Urinalysis Parameters

    Urine samples were analyzed for glucose, ketones, occult blood and protein by dipstick method. The dipstick test results are read as Negative, Trace, 1+, 2+, 3+, 4+ indicating proportional concentrations in the urine sample. Normal range for dipstick test results are 'negative' results. Urine potential of hydrogen (pH) and specific gravity were also analyzed. pH is measured on a numeric scale of 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Urine specific gravity is a measure of the concentration of solutes in the urine and indicated as ratio of urine density to water density. The normal ranges for pH: 4.8 to 7.4; and for specific gravity: 1.003 to 1.03. Number of participants with abnormal results in any urinalysis parameters are presented.

    Measured: Up to Day 71

  6. Number of Participants With Injection Site Reaction

    Local tolerability as measured by injection site reaction example: induration, erythema, edema, rash, pruritis or pain. Number of participants with any injection site reaction are presented.

    Measured: Up to Day 71

  7. Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events

    An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented.

    Measured: Up to Day 71

Timeline

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

  1. First posted23 Oct 2019
  2. Study start28 Oct 2019
  3. Primary completion14 Jan 2020
  4. Study completion14 Jan 2020

Resources

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
Model description
Subjects will be randomized in a 1:2 ratio to receive one treatment of either IV or SC administration of belimumab 200 mg.
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136145
Sponsor's protocol ID
209629
Status last verified
Nov 2020
First submitted
21 Oct 2019
Last updated
28 Dec 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Meng X, Wang Q, Wu S, Pu D, Zhang A, Fang S, Zhou X, Lu H. Pharmacokinetics and Safety of Intravenous and Subcutaneous Auto-injector Single-dose Belimumab in Healthy Chinese Volunteers: A phase 1, Randomized, Open-label Study. Rheumatol Ther. 2021 Dec;8(4):1711-1724. doi: 10.1007/s40744-021-00366-0. Epub 2021 Sep 23.

    PubMed 34554352

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Belimumab for IV and Belimumab for SC in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in China.

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 7 inclusion and 25 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 28 Dec 2020. 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 China. 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 Dec 2020). 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?

Serum Concentration of Belimumab Following Intravenous Administration (time frame: Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion). The study lists 2 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 NCT04136145, which also lists 1 linked publication.

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 28 Dec 2020.

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