Systemic Lupus Erythematosus
Conditions
Keywords
Pharmacokinetics, Phase 1, Healthy Subjects, Comparability, Belimumab
Brief 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. 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.
Interventions
DRUGBelimumab 200 mg/mL
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PK assessment for Cmax, AUC(0-t), AUC(0-inf) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability assessment including Adverse events (AEs), serious adverse events (SAEs), changes in laboratory values, and vital signs | From Screening upto Day 70 | 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. |
Countries
United States
Outcome results
None listed